syngo.via View&GO

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Siemens Healthcare GmBH Frederike Jakob Regulatory Affairs Manager Siemensstraße 1, Forchheim Erlangen, Bavaria Germany #### Re: K221501 October 14, 2022 Trade/Device Name: syngo.via View&GO Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: September 14, 2022 Received: September 15, 2022 Dear Frederike Jakob: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221501 Device Name syngo.via View&GO VA30A Indications for Use (Describe) syngo.via View&GO is indicated for image rendering and post-processing of DICOM images to support the interpretation in the field of radiology, nuclear medicine and cardiology. 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." {3}------------------------------------------------ # 510(k) Summary 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. Date prepared: June 29, 2022 - 1. Submitter: Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany Establishment Registration Number: 3004977335 #### 2. Contact Person: Ms. Frederike Jakob Regulatory Affairs Manager Siemens Healthcare GmbH, Siemensstr. 1 91301 Forchheim Germany E-mail: Frederike.Jakob(@siemens-healthineers.com Telephone: +49 (0)162 109 2694 Fax: +49 (9191) 18-4404 #### 3. Device Name and Classification: | Trade Name: | syngo.via View&GO (Version VA30A) | |-----------------------|-------------------------------------------------------| | Classification Name: | Medical Image Management and Processing System (PACS) | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892.2050 | | Device Class: | Class II | | Product Code: | LLZ | #### 4. Legally Marketed Predicate Device: | Trade Name: | syngo.via View&GO (Version VA20A) | |-----------------------|----------------------------------------------------------------------------------| | 510(k) Clearance: | K201477 | | Clearance Date: | July 1, 2020 | | Classification Name: | Picture Archiving and Communications System | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892.2050 | | Device Class: | Class II | | Product Code: | LLZ | | Recall Information: | This predicate device has not been the subject of any<br>design related recalls. | {4}------------------------------------------------ # 5. Device Description: Siemens Healthcare GmbH intends to market the Medical Image Management and Processing System, syngo.via View&GO, software version VA30A. This 510(k) submission describes several modifications to the previously cleared predicate device, syngo.via View&GO, software version VA20A. syngo.via View&GO is a software-only medical device, which is delivered by download to be installed on common IT hardware. This hardware has to fulfil the defined requirements. Any hardware platform that complies to the specified minimum hardware and software requirements and with successful installation verification and validation activities can be supported. The hardware itself is not seen as part of the medical device syngo.via View&GO and therefore not in the scope of this 510(k) submission. syngo.via View&GO provides tools and features to cover the radiological tasks preparation for reading, reading images and support reporting. syngo.via View&GO supports DICOM formatted images and objects. syngo.via View&GO is a standalone viewing and reading workplace. This is capable of rendering the data from the connected modalities for the post processing activities. syngo.via View&GO provides the user interface for interactive image viewing and processing with a limited short-term storage which can be interfaced with any Long-term storage (e.g. PACS) via DICOM syngo.via View&GO is based on Microsoft Windows operating systems. syngo.via View&GO supports various monitor setups and can be adapted to a range of image types by connecting different monitor types. The subject device and the predicate device share fundamental scientific technology. This device description holds true for the subject device. syngo.via View&GO, software version VA30A, as well as the predicate device, syngo.via View&GO, software version VA20A. #### 6. Intended Purpose: #### 6.1 Intended Use syngo.via View&GO is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options. syngo.via View&GO supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The subject device and the predicate device share an identical intended use. {5}------------------------------------------------ ## 6.2 Indications for Use syngo.via View&GO is indicated for image rendering and post-processing of DICOM images to support the interpretation in the field of radiology, nuclear medicine and cardiology. The subject device and the predicate device share identical indications for use. The indications for use fall within the scope of the intended use. #### 6.3 Contraindications The system is not indicated for mammography images for diagnosis in the U.S. The application is not to be used as an archiving device for patients' image data. The application is not to be used as a sole basis for clinical decisions but further evidence has to be taken into account. The subject device and the predicate device share substantially identical contraindications. ## 6.4 Patient Target Population syngo.via View&GO has neither limitations concerning the patient population (e.g. age, weight, health, condition) nor limitations concerning region of body or tissue type. The patient target population is identical for the subject device and the predicate device. {6}------------------------------------------------ # 7. Summary of Differences between the Subject Device and the Predicate Device: The following table compares the functionality of syngo.via View&GO VA30A to the predicate device syngo.via View&GO VA20A: | | Subject device | Predicate device | Comparison | Impact to<br>Safety &<br>Effectiveness | |---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name<br>and version (K<br>number) | syngo.via View&GO<br>(Version VA30A) | syngo.via View&GO<br>Version VA20A<br>(K201477) | New product<br>version | NA | | Manufacturer | Siemens Healthcare<br>GmbH | Siemens Healthcare<br>GmbH | Identical | NA | | Intended use | syngo.via View&GO is<br>a software solution<br>intended to be used for<br>viewing, manipulation,<br>communication, and<br>storage of medical<br>images.<br><br>It can be used as a<br>stand-alone device or<br>together with a variety<br>of cleared and<br>unmodified syngo based<br>software options.<br><br>syngo.via View&GO<br>supports interpretation<br>and evaluation of<br>examinations within<br>healthcare institutions,<br>for example, in<br>Radiology, Nuclear<br>Medicine and<br>Cardiology<br>environments.<br><br>The system is not<br>intended for the<br>displaying of digital<br>mammography images<br>for diagnosis in the U.S. | syngo.via View&GO is<br>a software solution<br>intended to be used for<br>viewing, manipulation,<br>communication, and<br>storage of medical<br>images.<br><br>It can be used as a<br>stand-alone device or<br>together with a variety<br>of cleared and<br>unmodified syngo based<br>software options.<br><br>syngo.via View&GO<br>supports interpretation<br>and evaluation of<br>examinations within<br>healthcare institutions,<br>for example, in<br>Radiology, Nuclear<br>Medicine and<br>Cardiology<br>environments.<br><br>The system is not<br>intended for the<br>displaying of digital<br>mammography images<br>for diagnosis in the U.S. | Identical | NA | | Software<br>architecture | Standalone workplace<br>system that is logically<br>broken down to<br>syngo.via View&GO<br>subsystems.<br><br>Subsystems are further<br>broken down to syngo<br>software options. | Standalone workplace<br>system that is logically<br>broken down to<br>syngo.via View&GO<br>subsystems.<br><br>Subsystems are further<br>broken down to syngo<br>software options. | Identical | NA | | | Subject device | Predicate device | Comparison | Impact to<br>Safety &<br>Effectiveness | | Image<br>communication | Standard network<br>protocols like TCP/IP<br>and standard<br>communication<br>protocol DICOM. | Standard network<br>protocols like TCP/IP<br>and standard<br>communication<br>protocol DICOM. | Identical | NA | | Imaging<br>algorithms | - Multiplanar<br>reconstruction<br>(MPR)<br>- Maximum and<br>Minimum Intensity<br>Projection<br>(MIP/MinIP)<br>- Volume Rendering<br>Technique (VRT)<br>with additional<br>edge and surface<br>enhancements and<br>control over<br>rendering<br>parameters<br>- Shaded Surface<br>Display (SSD)<br>- Digitally<br>Reconstructed<br>- Radiograph<br>- Editor functionality<br>(e.g. ClipBox)<br>- Registration<br>- Anatomical<br>registration<br>- Region growing<br>- Automatic Spine<br>Labeling, also for<br>ribs in CT thorax<br>scans 1<br>- Reprocessing X-<br>ray projection<br>images into 3D<br>image and<br>Topograms 15<br>- FASTAlign | - Multiplanar<br>reconstruction<br>(MPR)<br>- Maximum and<br>Minimum Intensity<br>Projection<br>(MIP/MinIP)<br>- Volume Rendering<br>Technique (VRT)<br>with additional<br>edge and surface<br>enhancements and<br>control over<br>rendering<br>parameters<br>- Shaded Surface<br>Display (SSD)<br>- Digitally<br>Reconstructed<br>- Radiograph<br>- Editor functionality<br>(e.g. ClipBox)<br>- Registration<br>- Anatomical<br>registration<br>- Region growing<br>- Automatic Spine<br>Labeling, also for<br>ribs in CT thorax<br>scans 2 (“Rib<br>labeling”)<br>- Reprocessing X-<br>ray projection<br>images into 3D<br>image and<br>Topograms 16 | Similar:<br>Algorithms<br>underwent<br>bug-fixing and<br>minor<br>improvements<br>. No re-<br>training or<br>change in<br>algorithm<br>models was<br>performed. | The changes<br>between the<br>predicate device<br>and the subject<br>device doesn't<br>impact the safety<br>and effectiveness<br>of the subject<br>device as the<br>necessary<br>measures were<br>taken for the<br>safety and<br>effectiveness of<br>the subject<br>device | | Quantitative<br>algorithms | Distance, angle &<br>angle-on-stack, VOI and<br>ROI measurements | Distance, angle, VOI<br>and ROI measurements | Angle-Tool<br>was extended<br>with Angle- | The changes<br>between the<br>predicate device<br>and the subject | | | Subject device | Predicate device | Comparison | Impact to<br>Safety &<br>Effectiveness | | | | | on-Stack<br>functionality | device doesn't<br>impact the safety<br>and effectiveness<br>of the subject<br>device as the<br>necessary<br>measures were<br>taken for the<br>safety and<br>effectiveness of<br>the subject<br>device | | Supported Image<br>Generating<br>Modalities | The following Image<br>types are supported by<br>syngo.via View&GO:<br>- CT Image<br>(Computed<br>Tomography)<br>- MR Image<br>(Magnetic<br>Resonance)<br>- NM Image<br>(Nuclear Medicine)<br>- XA Image (X-Ray<br>Angiography)<br>- US Image<br>(Ultrasound)<br>- DX Image (Digital<br>Radiography)<br>- DICOM secondary<br>capture objects | The following Image<br>types are supported by<br>syngo.via View&GO:<br>- CT Image<br>(Computed<br>Tomography)<br>- MR Image<br>(Magnetic<br>Resonance)<br>- NM Image<br>(Nuclear Medicine)<br>- XA Image (X-Ray<br>Angiography)<br>- US Image<br>(Ultrasound)<br>- DX Image (Digital<br>Radiography)<br>- DICOM secondary<br>capture objects | Identical | NA | | Image data<br>Compression | Receive & Store:<br>Images are received and<br>stored as received<br>without any change in<br>the compression format.<br><br>Display:<br>Images are displayed as<br>received without any<br>change in the<br>compression.<br><br>Lossy compression<br>images are displayed<br>with an indication to the<br>user with the<br>compression ratio. | Receive & Store:<br>Images are received and<br>stored as received<br>without any change in<br>the compression format.<br><br>Display:<br>Images are displayed as<br>received without any<br>change in the<br>compression.<br><br>Lossy compression<br>images are displayed<br>with an indication to the<br>user with the<br>compression ratio. | Identical | NA | | | Subject device | Predicate device | Comparison | Impact to<br>Safety &<br>Effectiveness | | | To DICOM Node:<br>Images are sent as per<br>the DICOM<br>negotiation.<br>Uncompressed is<br>preferred and lossy<br>compression is not<br>supported. | To DICOM Node:<br>Images are sent as per<br>the DICOM<br>negotiation.<br>Uncompressed is<br>preferred and lossy<br>compression is not<br>supported. | | | | | To Exchangeable<br>media: Images exported<br>as stored in the local<br>storage. | To Exchangeable<br>media: Images exported<br>as stored in the local<br>storage. | | | | | Supported<br>Compressions for<br>export: lossless<br>compression<br>algorithms, JPEG,<br>JPEG 2000 and RLE. | Supported<br>Compressions for<br>export: lossless<br>compression<br>algorithms, JPEG,<br>JPEG 2000 and RLE. | | | | Operating<br>system | Workplace:<br>Microsoft Windows 10<br>- 64 bit or higher<br>Microsoft Windows 7 –<br>64 bit SP1<br>(for update only) | Workplace:<br>Microsoft Windows 10<br>- 64 bit or higher<br>Microsoft Windows 7 –<br>64 bit SP1<br>(for update only) | Identical | NA | | Impact on Image<br>Generating<br>Devices | None.<br>syngo.via View&GO is<br>a pure post processing<br>software and there is no<br>influence on the image<br>generating devices | None.<br>syngo.via View&GO is<br>a pure post processing<br>software and there is no<br>influence on the image<br>generating devices | NA as both<br>the devices do<br>not impact the<br>Image<br>generating<br>devices. | NA | | CAD<br>Functionalities | None.<br>No automated<br>diagnostic<br>interpretation<br>capabilities like CAD<br>are included. All image<br>data are to be<br>interpreted by trained<br>personnel. | None.<br>No automated<br>diagnostic<br>interpretation<br>capabilities like CAD<br>are included. All image<br>data are to be<br>interpreted by trained<br>personnel. | NA as both<br>the devices<br>don't support<br>any CAD<br>functionalities<br>. | NA | | Software self-<br>test / checks | Alert the user in case<br>the data transfer is<br>interrupted to the<br>connected DICOM<br>node.<br><br>Hardware / Operating<br>system compatibility<br>check during<br>Installation. | Alert the user in case<br>the data transfer is<br>interrupted to the<br>connected DICOM<br>node.<br><br>Hardware / Operating<br>system compatibility<br>check during<br>Installation. | Identical | NA | | | Subject device | Predicate device | Comparison | Impact to<br>Safety &<br>Effectiveness | | | Display Compatibility<br>Check supports the end<br>user to qualify the<br>system for proper<br>diagnostic use. | Display Compatibility<br>Check supports the end<br>user to qualify the<br>system for proper<br>diagnostic use. | | | | Cyber Security | - User access control<br>- Audit trails<br>- Documentation of<br>- system security<br>information,<br>- Network traffic &<br>- Firewall control<br>- Support of virus /<br>- malware protection. | - User access control<br>- Audit trails<br>- Documentation of<br>- system security<br>information,<br>- Network traffic &<br>- Firewall control<br>- Support of virus /<br>- malware protection. | Identical | NA | | Hardware | Hardware is not<br>understood as part of the<br>medical device but<br>needs to comply with<br>the minimum<br>requirements as<br>specified by syngo.via<br>View&GO. | Hardware is not<br>understood as part of<br>the medical device but<br>needs to comply with<br>the minimum<br>requirements as<br>specified by syngo.via<br>View&GO. | Identical | NA | | Software Functionalities | | | | | | Graphical User<br>Interface | Yes, with reduced<br>color palette, clearer<br>structure and text<br>labels on icons. | Yes, with reduced color<br>palette, clearer structure<br>and text labels on icons | Similar - The<br>changes are<br>limited to the<br>common look<br>and feel<br>based on<br>Siemens<br>Healthineers<br>User<br>Interface<br>Style Guide. | The changes<br>between the<br>predicate device<br>and the subject<br>device doesn't<br>impact the safety<br>and effectiveness<br>of the subject<br>device as the<br>necessary<br>measures were<br>taken for the<br>safety and<br>effectiveness of<br>the subject<br>device. | | Patient Browser | Yes, with simplified<br>search functionality,<br>clearer structure of<br>search results, image<br>preview, unlimited<br>search results, periodic<br>updates of search<br>results. | Yes, with simplified<br>search functionality,<br>clearer structure of<br>search results, image<br>preview, unlimited<br>search results, periodic<br>updates of search<br>results. | Identical | NA | | | Subject device | Predicate device | Comparison | Impact to<br>Safety &<br>Effectiveness | | Series navigator | The Series Navigator<br>lists all currently<br>loaded data within a<br>workflow. | Yes, the Series<br>Navigator lists all<br>currently loaded data<br>within a workflow. | Identical | NA | | Findings /<br>Reporting | No, reporting support<br>is provided to create<br>reports using any 3rd<br>party reporting tool.<br>Hence the findings<br>also cannot be<br>navigated. | No, reporting support is<br>provided to create<br>reports using any 3rd<br>party reporting tool.<br>Hence the findings also<br>cannot be navigated. | Identical | NA | | Import and<br>export of data | Import of DICOM data<br>from network nodes or<br>external media, and of<br>DICOM-compliant or<br>non DICOM-<br>compliant data from<br>external media and<br>Windows file system.<br>Export to USB,<br>Windows file system,<br>or other DICOM<br>nodes. | Import of DICOM data<br>from network nodes or<br>external media, and of<br>DICOM-compliant or<br>non DICOM-<br>compliant data from<br>external media and<br>Windows file system.<br>Export to USB,<br>Windows file system,<br>or other DICOM<br>nodes. | Identical | NA | | Archiving data | Data can be sent to an<br>archive if syngo.via<br>View&GO is<br>connected to a PACS<br>or corresponding<br>DICOM node. | Data can be sent to an<br>archive if syngo.via<br>View&GO is<br>connected to a PACS<br>or corresponding<br>DICOM node. | Identical | NA | | Ranges | Yes, parallel, radial,<br>Radial sliced, Curved<br>and Spine ranges are<br>supported.<br>Additionally,<br>Anatomical Range<br>presets 3 can be<br>created. | Yes, parallel, radial,<br>Radial sliced, Curved<br>and Spine ranges are<br>supported.<br>Additionally,<br>Anatomical Range<br>presets 4 can be<br>created. | Spine Ranges<br>and Range<br>presets are<br>also<br>supported for<br>MR images<br>in the subject<br>device. | This difference<br>between the<br>predicate device<br>and the subject<br>device doesn't<br>impact the safety<br>and effectiveness<br>of the subject<br>device as the<br>necessary<br>measures were<br>taken for the<br>safety and | | | Subject device | Predicate device | Comparison | Impact to<br>Safety &<br>Effectiveness | | |…