SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO

{0}------------------------------------------------ April 13, 2018 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 40 Liberty Blvd. MALVERN PA 19355 ### Re: K173632 Trade/Device Name: SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Now, SOMATOM go.Up. and Scan&Go Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 15, 2018 Received: March 20, 2018 Dear Ms. Mangum: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara For Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. There is a black line underneath the word. | DEPARTMENT OF HEALTH AND HUMAN SERVICES | |-----------------------------------------| | Food and Drug Administration | | <b>Indications for Use</b> | | Form Approved: OMB No. 0910-0120 | |----------------------------------| | Expiration Date: 06/30/2020 | | See PRA Statement below. | | 510(k) Number (if known) | K173632 | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | SOMATOM go.Up | | Indications for Use (Describe) | This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis.<br>The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.<br>This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. | | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------|---------------------------------------------| | <span style="text-decoration: underline;"></span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. There is a black line underneath the word. | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2020 | |-------------------------------------------------------------------------|-----------------------------------------------------------------| | Indications for Use | See PRA Statement below. | | 510(k) Number (if known) | | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | SOMATOM go. Top | | Indications for Use (Describe) | This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. | | | The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. | | | This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung | | | Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. | | Type of Use (Select one or both, as applicable) | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. There is a black line underneath the word. #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) Device Name SOMATOM go.Now Indications for Use (Describe) This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. A black line is located underneath the word. | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2020<br>See PRA Statement below. | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number (if known) | | | Device Name | SOMATOM go.All | | Indications for Use (Describe) | | | | This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. | | | The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. | | | This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. | | Type of Use (Select one or both, as applicable) | | | Prescription Use (Part 21 CFR 801 Subpart D) | <div></div> | | | Over-The-Counter Use (21 CFR 801 Subpart C) | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. | | | *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | | | Department of Health and Human Services | | | Food and Drug Administration<br>Office of Chief Information Officer | | | Paperwork Reduction Act (PRA) Staff | | | PRAStaff@fda.hhs.gov<br>"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of | | | information unless it displays a currently valid OMB number." | | FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The word is written in a light blue color. There is a black line underneath the word. | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120 | |-------------------------------------------------------------------------|---------------------------------------------------------| | Indications for Use | Expiration Date: 06/30/2020<br>See PRA Statement below. | | 510(k) Number (if known) | | |--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Scan&GO | | Indications for Use (Describe) | The in-room scan application is a planning and information system designed to perform the necessary functions required for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the scanner.<br>The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using special protocols | | Type of Use (Select one or both, as applicable) | <div> <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. The word is displayed horizontally and is the main focus of the image. #### 510(K) SUMMARY FOR #### SOMATOM GO.PLATFORM SCANNERS Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: March 15, 2018 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. #### l. Submitter Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number 2240869 Location of Manufacturing Site (1) Siemens Healthcare GmbH Siemensstr. 1 D-91301 Forchheim, Germany Establishment Registration Number 3004977335 Location of Manufacturing Site (2) SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD 278 Zhou Zhu Rd Shanghai, CHINA, 201318 Establishment Reqistration Number: 3003202425 #### Contact Person: Kimberly Mangum Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Phone: (610) 448-6477 Email: kimberly.mangum@siemens-healthineers.com #### II. Device Name and Classification | Product Name: | SOMATOM go.All | |--------------------------------|---------------------------------------------| | Propriety Trade Name: | SOMATOM go.All | | Classification Name: | Computed Tomography X-Ray System | | Secondary Classification Name: | Picture Archiving and Communications System | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892.1750 | | Secondary CFR Section: | 21 CFR 892.2050 | | Device Class: | Class II | | Primary Product Code: | JAK | | Secondary Product Code: | LLZ | {8}------------------------------------------------ Product Name: Propriety Trade Name: Classification Name: Secondary Classification Name: Classification Panel: CFR Section: Secondary CFR Section: Device Class: Primary Product Code: Secondary Product Code: Product Name: Propriety Trade Name: Classification Name: Secondary Classification Name: Classification Panel: CFR Section: Secondary CFR Section: Device Class: Primary Product Code: Secondary Product Code: Product Name: Propriety Trade Name: Classification Name: Secondary Classification Name: Classification Panel: CFR Section: Secondary CFR Section: Device Class: Primary Product Code: Secondary Product Code: Product Name: Propriety Trade Name: Classification Name: Secondary Classification Name: Classification Panel: CFR Section: Secondary CFR Section: Device Class: Product Code: Secondary Product Code: #### III. Predicate Device Primary Predicate Device: Product Name: Propriety Trade Name: 510(k) Number: Clearance Date: Classification Name: Secondary Classification Name: Classification Panel: CFR Section: Secondary CFR Section: Device Class: SOMATOM go.Top SOMATOM go.Top Computed Tomography X-Ray System Picture Archiving and Communications System Radiology 21 CFR §892.1750 21 CFR 892.2050 Class II JAK LLZ SOMATOM go.Now SOMATOM go.Now Computed Tomography X-Ray System Picture Archiving and Communications System Radiology 21 CFR §892.1750 21 CFR 892.2050 Class II JAK LLZ SOMATOM go.Up SOMATOM go.Up Computed Tomography X-Ray System Picture Archiving and Communications System Radiology 21 CFR §892.1750 21 CFR 892.2050 Class II JAK LLZ Scan&GO Scan&GO Computed Tomography X-ray System Picture Archiving and Communications System Radiology 21 CFR §892.1750 21 CFR §892.2050 Class II JAK LLZ SOMATON go.Now, SOMATOM go.Up SOMATON go.Now, SOMATOM go.Up K163296 March 21, 2017 Computed Tomography X-Ray System Picture Archiving and Communications System Radiology 21 CFR §892.1750 21 CFR 892.2050 Class II {9}------------------------------------------------ Primary Product Code: JAK Secondary Product Code: LLZ Recall Information: All applicable recalls are considered and addressed as part of the design control process #### Secondary Predicate Devices: Product Name: Propriety Trade Name: 510(k) Number: Clearance Date: Classification Name: Secondary Classification Name: Classification Panel: CFR Section: Secondary CFR Section: Device Class: Product Code: Secondary Product Code: Recall Information: Scan&GO Scan&GO K163297 March 24, 2017 Computed Tomography X-ray System Picture Archiving and Communications System Radiology 21 CFR §892.1750 21 CFR §892.2050 Class II JAK LLZ There are currently no design related recalls for this device ### IV. Device Description The SOMATOM go.Platform is comprised of the following 4 CT scanners and optional mobile workflow: - SOMATOM go.Up ● - SOMATOM go.Now ● - SOMATOM go.Top ● - o SOMATOM go.All - Scan&GO Mobile Medical Application (optional mobile workflow component) The CT scanners feature one continuously rotating tube-detector system and function according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The above referenced CT scanners produce CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors as an aid in diagnosis and treatment preparation. The computer system delivered with the CT scanner is able to run optional post processing applications. The Scan&GO mobile workflow is an optional planning and information software designed to perform the necessary functions required for planning and controlling of the workflow of the SOMATOM go.Platform CT scanners. Scan&GO can be operated on a Siemens provided tablet or a commercially available that meets certain minimum technical requirements. It allows users to work in close proximity to the scanner and the patient. Specifically Scan&GO allows control/display of the following software interactions via a wireless tablet that meets certain minimum requirements: - Selection of patients O - Selection of pre-defined protocols O - Scan parameter display o - Patient table position display and gantry tilt parameter display O - Tools and instruction message area, Patient table position planning area O - Physiological data display O - Patient data display (e.g. date of birth, name) O - Display of acquired topogram and tomogram images O - O Finalization of exam (close patient) {10}------------------------------------------------ - NOTE: Scan&GO does not support storage of images. Additionally, Scan&GO cannot O trigger a scan or radiation release. The software version for the SOMATOM go.Platform, syngo CT VA20 (SOMARIS/10 syngo CT VA20), is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The software platform SOMARIS/10 syngo CT VA20 is designed to provide a plugin interface to support the optional Scan&GO mobile workflow as well as integrate potential advanced post processing tasks, tools, or extendable functionalities. Software version syngo CT VA20 (SOMARIS/10 syngo CT VA20) is an update to software version syngo CT VA10A (SOMARIS/10 syngo CT VA20) which was cleared for the predicate devices, and supports the same plugin interfaces for the optional Scan&GO mobile workflow and integration of post-processing tasks as the predicate devices. The SOMATOM go.Platform will support the following modifications/further developments in comparison to the predicate devices: Subject Device: SOMATOM qo. Now and SOMATOM go.Up: Modified from the primary predicate device SOMATOM go.Now and SOMATOM go.Up to support the following: - 1) Modified Indication for Use Statement - 2) New/Modified Hardware - Modified Patient Table . - . New Injector Arm (optional) - Software version SOMARIS/10 syngo CT VA20 3) - Modified software to support CT Intervention from ICS console ● - Modified software to support CT Intervention as optional mobile workflow with Scan&GO ● - . Modified Inline Vessel Ranges - Cardio CPR (curved planar reformation) - Modified Dynamic Serio Mode for perfusion . - Modified basic post processing features o - o Modified HD FoV - 4) Update 510(k) Information provided as Appendix H #### Subject Devices: SOMATOM go.All and SOMATOM go.Top Scanners: Further developments of the primary predicate device SOMATOM go.Now and SOMATOM go.Up CT scanners including the following modifications: - New Marketing Name: SOMATOM go.All and SOMATOM go.Top 1) - 2) Modified Indications for Use Statement - 3) New/Modified Hardware - Modified Patient Table ● - New Injector Arm (optional) . - . Modified Generator - Modified Stellar Detector - 0 Modified X-Ray Tube - o New Iniector Arm (optional) - Software version SOMARIS/10 syngo CT VA20 4) - Modified software to support CT Intervention from ICS console ● - Modified software to support CT Intervention as optional mobile workflow with Scan&GO ● - Modified Inline Vessel Ranges Cardio CPR (curved planar reformation) ● - Modified Dynamic Serio Mode for perfusion ● - Modified basic post processing features - Modified HD FoV - Modified High Power 70 ● - o Modified CARE kV - Modified Adaptive Cardio Sequence o - Support of TwinBeam Scan Mode (SOMATOM go.Top only) {11}------------------------------------------------ - . Support of Inline DE (Radial Ranges, Parallel Ranges) (SOMATOM go.Top only) Subject Device: Scan&GO Mobile Workflow (optional): Further developments of mobile medical application software Scan&GO supported by SOMATOM go.Platform CT Scanner Systems including the following modifications: - 1) Software version SOMARIS/10 syngo VA20 - Optional new workflow - Guide&GO CT-Guided Intervention A comparison of these modifications with respect to the predicate devices is provided in the "Comparison of Technological Characteristics with the Predicate Device" section below. As cleared in the predicate device, the subject device SOMATOM go.Now CT scanner is available in a 16 row 32 slice configuration and SOMATOM go.Up CT scanner is available in a 32 row 64 slice configuration. The configurations for the subject devices SOMATOM go.Now and SOMATOM go.Up will remain unchanged from the predicate device. The subject device SOMATOM go.All scanner will be available in a 32 row 64 slice configuration and the SOMATOM go.Top scanner will be available in 64 row 128 slice configuration. A summary of the differences between the subject device CT scanner configurations is provided as Table 1 and Table 2 below. | Subject Device Comparison | | | |----------------------------------|----------------------------------|---------------| | Key specifications | SOMATOM go.Now | SOMATOM go.Up | | Physical Rows | 16 | 32 | | Slice width (mm) | 0.7 | 0.7 | | z coverage (mm) | 11.2 | 22.4 | | Rotation time (s) | 0.8, 1.0, 1.5 | 0.8, 1.0, 1.5 | | FoV (cm) | 50 | 50 | | Max scan range (cm) | 125 | 160 | | | 160 | | | Bore size (cm) | 70 | 70 | | Gantry tilt | Not available | Available | | Table Vertical Movement | Standard: No<br>Optional: YES | Available | | Table Load (kg) | Table Load: 160<br>Optional: 227 | 227 | | Power (kW) | 32 | 32 | | XTA X-ray Tube | Chronon | Chronon | | Tube heat capacity (MHU) | 3.5 | 3.5 | | Recon speed (images/s) | 9 (optional 13) | 13 | | Detector width | 11.2 mm | 22.4 mm | | Iterative Reconstruction Methods | SAFIRE, iMAR | SAFIRE, iMAR | | Spiral Scan | Available | Available | Table 1: SOMATOM go.Now and SOMATOM go.Up comparable properties {12}------------------------------------------------ | Subject Device Comparison | | | |---------------------------------------|----------------------------------|----------------------------------| | Key specifications | SOMATOM go.All | SOMATOM go.Top | | Physical Rows | 32 | 64 | | Slice width (mm) | 0.7 | 0.6 | | z coverage (mm) / Detector width | 22.4 | 38.4 | | Rotation time (s) | 0.33, 0.5, 1.0 | 0.33, 0.5, 1.0 | | FoV (cm) | 50 | 50 | | Max scan range (cm) | 160 | 160 | | Bore size (cm) | 70 | 70 | | Gantry tilt | Available | Available | | Table Vertical Movement | Available | Available | | Table Load (kg) | Table Load: 227<br>Optional: 300 | Table Load: 227<br>Optional: 300 | | Power (kW) | 75 | 75 | | XTA X-ray Tube | Athlon | Athlon | | Tube heat capacity (MHU) | >=6 | >=6 | | Iterative Reconstruction Control Unit | IRS-1c | IRS-1c | | Iterative Reconstruction Methods | SAFIRE<br>iMAR | SAFIRE<br>iMAR | | Spiral Scan | Available | Available | Table 2: SOMATOM go.All and SOMATOM go.Top comparable properties ### V. Indications for Use #### SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All and SOMATOM go.Top: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. #### Scan&GO: The in-room scan application is a planning and information system designed to perform the necessary functions required for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the scanner. The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using special protocols {13}------------------------------------------------ ### VI. Comparison of Technological Characteristics with the Predicate Device The SOMATOM go.Platform scanners and optional Scan&GO mobile workflow provide the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate devices. The software and hardware components of the SOMATOM go.Platform have been modified or improved in comparison to the predicate devices to support enhanced device functionality when compared to the predicate devices. Software version SOMARIS/10 syngo CT VA20 supports software features such as extended functionalities and GO technologies which provide interfaces to directly access optional post processing applications and are designed to enhance the user workflow. The intended use and fundamental scientific technology for the SOMATOM go.Platform remains unchanged from the predicate devices. #### At a high level, the subject and predicate devices are based on the following same technological elements: - Scanner Principle- Whole body X-Rav Computed Tomography Scanner ● - System Acquisition Continuously rotating tube detector system ● - Iterative Reconstruction Support of various iterative reconstruction methods ● - Workplaces Support of workplaces that include reconstruction and image evaluation . software - . Support of interfaces to access optional post-processing applications - Patient table configurations ● - . Tin filtration technology - Stellar detector technology - High Power 80 (High mA@low kV) . - Support of optional wired/wireless Remote Scan Control (RSC) ● - o Support of the optional Scan &GO mobile workflow #### The following technological differences exist between the subject device SOMATOM go.Now and SOMATOM go.Up and the predicate device SOMATOM go.Now and SOMATOM qo.Up: - Software version SOMARIS/10 syngo CT VA20 . - New iniector arm (optional) ● - Support of Intervention Workflow for Scan&GO The following technological differences exist between the subject device SOMATOM go.All and SOMATOM go.Top and the predicate device SOMATOM go.Now and SOMATOM go.Up: - Software version SOMARIS/10 syngo CT VA20 . - Athlon X-ray Tube . - Long scan range - 75 kW maximum power Generator ● - High Power 70 ● - New injector arm . - Software version SOMARIS/10 syngo CT VA20 - Support of Intervention Workflow for Scan&GO ● ### The following technological differences exist between the subject device Scan&GO and the predicate device Scan&GO: - Software version SOMARIS/10 syngo CT VA20 A tabular summary of the differences between the predicate and subject devices is provided as Table 3, Table 4 and Table 5 below: {14}------------------------------------------------ Table 3: Comparison of Technological Characteristics for SOMATOM go.Now and SOMATOM go.Up | Property | Subject Device<br>SOMATOM go.Now | Subject Device<br>SOMATOM go.Up | Primary Predicate<br>Device:<br>SOMATOM go.Now<br>SOMATOM go.Up<br>(K163296) | |--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------| | Type of CT<br>Scanner | whole body X-ray<br>computed tomography<br>scanner | whole body X-ray<br>computed tomography<br>scanner | whole body X-ray<br>computed tomography<br>scanner | | System<br>Hardware | continuously rotating tube<br>detector system | continuously rotating tube<br>detector system | continuously rotating tube<br>detector system | | Hardware | high voltage generator<br>with max power 32kW | high voltage generator<br>with max power 32kW | high voltage generator<br>with max power 32kW | | X-Ray Tube | Chronon | Chronon | Chronon | | kV Steps | 80kV, 110kV,130kV | 80kV, 110kV,130kV | 80kV, 110kV,130kV | | Selective<br>Photon Shield | Tin Filter Technology | Tin Filter Technology | Tin Filter Technology | | HMI & Gantry<br>Display | realized as wireless tablet<br>mobile medical<br>application software,<br>remote scan control<br>(wired/wireless) | realized as wireless tablet<br>mobile medical<br>application software,<br>remote scan control<br>(wired/wireless) | realized as wireless tablet<br>mobile medical<br>application software,<br>remote scan control<br>(wired/wireless) | | Software<br>Operating<br>System | Windows based<br>SOMARIS/10 syngo CT<br>VA20 | Windows based<br>SOMARIS/10 syngo CT<br>VA20 | Windows based<br>SOMARIS/10 syngo CT<br>VA10A | | | Software<br>Features | Basic Post Processing<br>Viewer | Basic Post Processing<br>Viewer | | Interface for Advanced<br>Post Processing<br>Application | | Interface for Advanced<br>Post Processing<br>Application | Interface for Advanced<br>Post Processing<br>Application | | Interface for Plugin (for<br>future advanced<br>visualization tools and<br>extended functionalities) | | Interface for Plugin (for<br>future advanced<br>visualization tools and<br>extended functionalities) | Interface for Plugin (for<br>future advanced<br>visualization tools and<br>extended functionalities) | | Interface to support an<br>optional mobile workflow<br>control application<br>software<br>Image Reconstruction<br>IT Hardening | | Interface to support an<br>optional mobile workflow<br>control application<br>software<br>Image Reconstruction<br>IT Hardening | Interface to support an<br>optional mobile workflow<br>control application<br>software<br>Image Reconstruction<br>IT Hardening | | Property | Subject Device<br>SOMATOM go.Now | Subject Device<br>SOMATOM go.Up | Primary Predicate<br>Device:<br>SOMATOM go.Now<br>SOMATOM go.Up<br>(K163296) | | Software Features | Data Exchange with<br>external SW client<br>(Teamplay) — allows to<br>copy scan protocols from<br>other systems | Data Exchange with<br>external SW client<br>(Teamplay) - allows to<br>copy scan protocols from<br>other systems | Data Exchange with<br>external SW client<br>(Teamplay) - allows to<br>copy scan protocols from<br>other systems | | Iterative Reconstruction<br>Methods | SAFIRE<br>iMAR | SAFIRE<br>iMAR | SAFIRE<br>iMAR | {15}------------------------------------------------ Table 4: Comparison of Technological Characteristics for SOMATOM go.All and SOMATOM go.Top | Property | Subject Device<br>SOMATOM go.All | Subject Device<br>SOMATOM go. Top | Primary Predicate<br>Device<br>SOMATOM go.Now<br>SOMATOM go.Up<br>(K163296) | |---------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | Type of CT<br>Scanner | whole body X-ray<br>computed tomography<br>scanner | whole body X-ray<br>computed tomography<br>scanner | whole body X-ray<br>computed tomography<br>scanner | | System | continuously rotating tube<br>detector system | continuously rotating tube<br>detector system | continuously rotating tube<br>detector system | | Hardware | high voltage generator<br>with max power 75kW | high voltage generator<br>with max power 75kW | high voltage generator<br>with max power 32kW | | X-Ray Tube | Athlon | Athlon | Chronon | | kV Steps | 70 kV / 80 kV / 90 kV /<br>100 kV / 110 kV / 120 kV<br>/ 130 kV / 140 kV | 70 kV / 80 kV / 90 kV /<br>100 kV / 110 kV / 120 kV<br>/ 130 kV / 140 kV | 80kV, 110kV,130kV | | Selective<br>Photon Shield | Tin Filter Technology | Tin Filter Technology | Tin Filter Technology | | single source<br>dual energy | N/A | Split Filter Technology<br>(TwinBeam Dual Energy) | N/A | | HMI & Gantry<br>Display | realized as wireless<br>tablet mobile medical<br>application software,<br>remote scan control<br>(wired/wireless) | realized as wireless<br>tablet mobile medical<br>application software,<br>remote scan control<br>(wired/wireless) | realized as wireless tablet<br>mobile medical<br>application software,<br>remote scan control<br>(wired/wireless) | | Software<br>Operating<br>System | Windows based<br>SOMARIS/10 syngo CT<br>VA20 | Windows based<br>SOMARIS/10 syngo CT<br>VA20 | Windows based<br>SOMARIS/10 syngo CT<br>VA10A | {16}------------------------------------------------ | Property | Subject Device<br>SOMATOM go.All | Subject Device<br>SOMATOM go. Top | Primary Predicate<br>Device<br>SOMATOM go.Now<br>SOMATOM go.Up<br>(K163296) | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------| | Software<br>Features | Basic Post Processing<br>Viewer | Basic Post Processing<br>Viewer | Basic Post Processing<br>Viewer | | | Interface for Advanced<br>Post Processing<br>Application | Interface for Advanced<br>Post Processing<br>Application | Interface for Advanced<br>Post Processing<br>Application | | | Interface for Plugin (for<br>future advanced<br>visualization tools and<br>extended functionalities) | Interface for Plugin (for<br>future advanced<br>visualization tools and<br>extended functionalities) | Interface for Plugin (for<br>future advanced<br>visualization tools and<br>extended functionalities) | | | Interface to support an<br>optional mobile workflow<br>control application<br>software | Interface to support an<br>optional mobile workflow<br>control application<br>software | Interface to support an<br>optional mobile workflow<br>control application<br>software | | | Image Reconstruction | Image Reconstruction | Image Reconstruction | | Software<br>Features | IT Hardening | IT Hardening | IT Hardening | | | Data Exchange with<br>external SW client<br>(Teamplay) – allows to<br>copy or transfer scan<br>protocols from / to other<br>systems | Data Exchange with<br>external SW client<br>(Teamplay) – allows to<br>copy or transfer scan<br>protocols from / to other<br>systems | Data Exchange with<br>external SW client<br>(Teamplay) –<br>allows to copy scan<br>protocols from other<br>systems | | | SAFIRE<br>iMAR | SAFIRE<br>iMAR | SAFIRE<br>iMAR | | Iterative<br>Reconstruction<br>Methods | SAFIRE<br>iMAR | SAFIRE<br>iMAR | SAFIRE<br>iMAR | ### Table 5: Scan&GO Mobile Workflow | | SOMATOM go.Platform Scanner | SOMATOM go.Platform Scanner | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technological<br>Characteristic | Frontend:<br>Subject Device<br>Scan&GO (VA20) | Frontend:<br>Predicate Device<br>Scan&GO (VA10)<br>(K163297) | | Software Operating<br>Platform | Windows based SOMARIS/10<br>syngo CT VA20 operating software | Windows based SOMARIS/10 syngo<br>CT VA10A operating software | | Supported Hardware | Detached commercially available<br>tablet that meets certain minimum<br>requirements. | Detached commercially available<br>tablet that meets certain minimum<br>requirements. | | Operating Software<br>Platform | Windows 10 and .Net is required as<br>operating platform | Windows 10 and .Net is required as<br>operating platform | | Connection to the<br>scanner | Wi-Fi connection | Wi-Fi connection | | Technological<br>Characteristic | SOMATOM go.Platform<br>Scanner…