uWS-CT

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June 24, 2019 Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao Regulatory Affairs Specialist NO. 2258 Chengbei Road Shanghai, Shanghai 201807 CHINA Re: K183170 Trade/Device Name: uWS-CT Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: May 28, 2019 Received: May 29, 2019 Dear Xin Gao: 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 vou, 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 medical devices and radiation-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, Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K183170 Device Name uWS-CT Indications for Use (Describe) uWS-CT is a software solution intended to be used for viewing, manipulation, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications: The CT Oncology application is intended to support fast-tracking routine diagnostic oncology, staging, and follow-up, by providing a tool for the user to perform the segmentation of suspicious lesions in lung or liver. The CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon. The CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw. The CT Lung Nodule application is intended to provide the user a tool for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies. The CT Vessel Analysis application is intended to provide a tool for viewing, manipulating CT vascular images. The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels. The CT Lung Density Analysis application is intended to segment pulmonary, lobes, and airway, providing the user quantitative parameters, structure information to evaluate the lung and airway. The CT Brain Perfusion application is intended to calculate the parameters such as: CBV, CBF, etc. in order to analyze functional blood flow information about a region of interest (ROI) in the brain. The CT Heart application is intended to segment heart and extract coronary artery. It also provides analysis of vascular stenosis, plaque and heart function. The CT Calcium Scoring application is intended to identify calcifications and calculate the calcium score. The CT Dynamic Analysis application is intended to provide visualization of the CT datasets over time with the 3D/4D display modes. The CT Bone Structure Analysis application is intended to provide visualization and labels for the ribs and spine, and support batch function for intervertebral disk. The CT Liver Evaluation application is intended to provide processing and visualization for liver segmentation and vessel extraction. It also provides a tool for the user to perform liver separation and residual liver segments evaluation. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ 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. 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Date of Preparation: May 28, 2019 ### Sponsor Identification 2. Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China Establishment Registration Number: 3011015597 Contact Person: Xin Gao Position: Regulatory Affairs Specialist Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com ### 3. Identification of Proposed Device Trade Name: uWS-CT Common Name: CT Image Post-Processing Software Model(s): uWS-CT Regulatory Information Classification Name: Picture archiving and communications system Classification: II Product Code: LLZ Regulation Number: 21 CFR 892.2050 Review Panel: Radiology ### 4. Identification of Predicate Device(s) Predicate Device 510(k) Number: K173001 Device Name: uWS-CT Reference Device#1 510(k) Number: K103480 Device Name: THORACIC VCAR Reference device#2 510(k) Number: K033326 # Page 1 of 14 {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is made up of a thick, dark vertical line and a shorter horizontal line that extends from the top of the vertical line to the left. ## Device Name: "Philips Plus" CT Scanner Reference device#3 510(k) Number: K090546 Device Name: nordicICE Software Reference device#4 510(k) Number: K113442 Device Name: 3Di including Viewing of Mammography images Reference device#5 510(k) Number: K150843 Device Name: syngo.via Reference device#6 510(k) Number: K120331 Device Name: syngo.CT Dynamic Angio Reference device#7 510(k) Number: K133643 Device Name: syngo.CT Liver Analysis Reference device#8 510(k) Number: K162025 Device Name: IntelliSpace Portal Platform #### 5. Device Description uWS-CT is a comprehensive software solution designed to process, review and analyze CT studies. It can transfer images in DICOM 3.0 format over a medical imaging network or import images from external storage devices such as CD/DVDs or flash drives. These images can be functional data, as well as anatomical datasets. It can be at one or more time-points or include one or more time-frames. Multiple display formats including MIP and volume rendering and multiple statistical analysis including mean, maximum and minimum over a user-defined region is supported. A trained, licensed physician can interpret these displayed images as well as the statistics as per standard practice. This proposed device contains the following modifications/improvements in comparison to the predicate device uWS-CT: 1) Modified Indications for Use Statement; 2) Modified CT Lung Density Analysis, CT Heart and CT Calcium Scoring application; {6}------------------------------------------------ Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED IMAGING" are in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is also in a bold, sans-serif font. The logo is simple and modern. - 3) Added some advanced applications: - . CT Brain Perfusion - CT Dynamic Analysis - . CT Bone Structure Analysis - CT Liver Evaluation ### 6. Indications for use uWS-CT is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications: - The CT Oncology application is intended to support fast-tracking routine diagnostic oncology, staging, and follow-up, by providing a tool for the user to perform the segmentation and volumetric evaluation of suspicious lesions in lung or liver. - The CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon. - . The CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw. - . The CT Lung Density Analysis application is intended to segment pulmonary, lobes, and airway, providing the user quantitative parameters, structure information to evaluate the lung and airway. - . The CT Lung Nodule application is intended to provide the user a tool for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies. - The CT Vessel Analysis application is intended to provide a tool for viewing, manipulating, and evaluating CT vascular images. - The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels. - . The CT Brain Perfusion application is intended to calculate the parameters such as: CBV, CBF, etc. in order to analyze functional blood flow information about a region of interest (ROI) in brain. - . The CT Heart application is intended to segment heart and extract coronary artery. It also provides analysis of vascular stenosis, plaque and heart function. - . The CT Calcium Scoring application is intended to identify calcifications and calculate the calcium score. - . The CT Dynamic Analysis application is intended to support visualization of the CT datasets over time with the 3D/4D display modes. # Page 3 of 14 {7}------------------------------------------------ Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is dark gray and has a white line running through the middle of it. The overall design is clean and modern. - The CT Bone Structure Analysis application is intended to provide visualization and labels for the ribs and spine, and support batch function for intervertebral disk. - . The CT Liver Evaluation application is intended to provide processing and visualization for liver segmentation and vessel extraction. It also provides a tool for the user to perform liver separation and residual liver segments evaluation. ### 7. Summary of Technological Characteristics uWS-CT is a medical diagnostic application for viewing, manipulation, 3D visualization, post-processing and comparison of medical images. After importing the DICOM image data into the system, the operator is able to perform image browsing and processing and can further obtain advanced information for diagnosis. This is identical to the predicate device. The following tables compare the main features, principles of operation, fundamental scientific technology and intended use of uWS-CT when compared to the predicate devices. ### Substantially Equivalent (SE) Comparison 8. Both the proposed and predicate device have the same general information, such as Device Classification Name, Product Code, Classification Panel, etc. and visualization and measurement technological features: - Image communication - Hardware /OS - Patient Administration - Review 2D ● - Review 3D - Filming - . . . Fusion - Inner View - Visibility - ROI/VOI - MIP Display - Compare The proposed and predicate device also have the same advanced applications in following: - CT Oncology - CT Dental Application - CT Colon Analysis ● - CT Vessel Analysis # Page 4 of 14 {8}------------------------------------------------ Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other and are in bold, sans-serif font. To the right of the words is a stylized "U" symbol. The symbol is a dark gray color and has a white line running vertically through the center. ### ● CT Lung Nodule The differences between the proposed and the predicate device are about advanced applications, and are listed as follows: - CT Lung density Analysis application has been modified, 6 new functions were added as follows. Substantial equivalence of these functions between the proposed and their corresponding reference device is discussed in Table 2. - Lung Contour Editing - . Pulmonary lobes Segmentation - . Airway Segmentation - . Airway Tree Extraction and Editing - Airway Contour Editing - . Statistical Analysis - CT Heart and CT Calcium Scoring applications have been modified. Substantial equivalence of these applications between the proposed and their corresponding reference device is discussed in Table 2. - The proposed device has added 4 new features to the predicate device. Substantial equivalence of these 4 features between the proposed and the corresponding reference device is also discussed in Table 2. - . CT Brain Perfusion - CT Dynamic Analysis - CT Bone Structure Analysis - . CT Liver Evaluation {9}------------------------------------------------ | Item | Proposed Device<br>uWS-CT | Predicate Device<br>uWS-CT(K173001) | Remark | |-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General | | | | | Device Classification<br>Name | Picture Archiving and Communications System | Picture Archiving and Communications System | Same | | Product Code | LLZ | LLZ | Same | | Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Same | | Device Class | II | II | Same | | Classification Panel | Radiology | Radiology | Same | | Advanced Application | Yes | Yes | The proposed device includes more applications, which is discussed in the following sections, than the predicate device. This difference will not impact the safety and effectiveness of the device. | | Intended Use | uWS-CT is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:<br>The CT Oncology application is intended to support fast-tracking routine diagnostic oncology, staging, and follow-up, by providing a tool for the user to perform the segmentation and volumetric evaluation of suspicious lesions in lung or liver. The CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon. | uWS-CT is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:<br>The CT Oncology application is intended to support fast-tracking routine diagnostic oncology, staging, and follow-up, by providing the segmentation and volumetric evaluation of suspicious lesions in lung or liver. | The intended use is supplemented. The proposed device includes more applications, which is discussed in the following sections, than the predicate device. This difference will not impact the safety and effectiveness of the device. | | Item | Proposed Device | Predicate Device | Remark | | | uWS-CT | uWS-CT(K173001) | | | | The CT Dental application is intended to provide the<br>user a tool to reconstruct panoramic and paraxial views<br>of jaw. The CT Lung Density Analysis application is intended<br>to segment pulmonary, lobes, and airway, providing the<br>user quantitative parameters, structure information to<br>evaluate the lung and airway. The CT Lung Nodule application is intended to provide<br>the user a tool for the review and analysis of thoracic CT<br>images, providing quantitative and characterizing<br>information about nodules in the lung in a single study,<br>or over the time course of several thoracic studies. The CT Vessel Analysis application is intended to<br>provide a tool for viewing, manipulating, and evaluating<br>CT vascular images. The Inner view application is intended to perform a<br>virtual camera view through hollow structures<br>(cavities), such as vessels. The CT Brain Perfusion application is intended to<br>calculate the parameters such as: CBV, CBF, etc. in<br>order to analyze functional blood flow information<br>about a region of interest (ROI) in brain. The CT Heart application is intended to segment heart<br>and extract coronary artery .It also provides analysis of<br>vascular stenosis, plaque and heart function. The CT Calcium Scoring application is intended to<br>identify calcifications and calculate the calcium score. The CT Dynamic Analysis application is intended to<br>support visualization of the CT datasets over time with<br>the 3D/4D display modes. The CT Bone Structure Analysis application is intended<br>to provide visualization and labels for the ribs and spine,<br>and support batch function for intervertebral disk. | The CT Colon Analysis application is<br>intended to provide the user a tool to<br>enable easy visualization and efficient<br>evaluation of CT volume data sets of the<br>colon. The CT Dental application is intended to<br>provide the user a tool to reconstruct<br>panoramic and paraxial views of jaw. The CT Lung Density application is<br>intended to provide the user a number of<br>density parameters and structure<br>information for evaluating tomogram<br>scans of the lung. The CT Lung Nodule application is<br>intended to provide the user a tool for the<br>review and analysis of thoracic CT<br>images, providing quantitative and<br>characterizing information about nodules<br>in the lung in a single study, or over the<br>time course of several thoracic studies. The CT Vessel Analysis application is<br>intended to provide a tool for viewing,<br>manipulating, and evaluating CT vascular<br>images. The Inner view application is intended to<br>perform a virtual camera view through<br>hollow structures (cavities), such as<br>vessels. | | | Item | Proposed Device<br>uWS-CT | Predicate Device<br>uWS-CT(K173001) | Remark | | | The CT Liver Evaluation application is intended to provide processing and visualization for liver segmentation and vessel extraction. It also provides a tool for the user to perform liver separation and residual liver segments evaluation. | | | Table 1 Comparison of general information {10}------------------------------------------------ Image /page/10/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is displayed in bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is composed of thick, vertical lines and a horizontal line at the top, creating a modern and abstract representation of the letter. {11}------------------------------------------------ Image /page/11/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is formed by two vertical lines connected by a horizontal line at the top, creating a shape that resembles a shield or a stylized letter U. {12}------------------------------------------------ | Application | Function name | Proposed<br>device<br>uWS-CT | Predicate device:<br>uWS-CT(K173001) | Reference device#1<br>AW SERVER<br>(K103480) | Remark | |-----------------------------|---------------------------------------|------------------------------|--------------------------------------|----------------------------------------------|-----------------| | CT Lung density<br>Analysis | Lung Segmentation | Yes | Yes | / | Same, no change | | | Calculation of Lung<br>Density | Yes | Yes | / | Same, no change | | | Histogram Analysis | Yes | Yes | / | Same, no change | | | Table Statistics | Yes | Yes | / | Same, no change | | | VRT Protocol Display | Yes | Yes | / | Same, no change | | | Save, Report, Print | Yes | Yes | / | Same, no change | | | Lung Contour Editing | Yes | / | Yes | Same | | | Pulmonary lobes<br>Segmentation | Yes | / | Yes | Same | | | Airway Segmentation | Yes | / | Yes | Same | | | Airway Tree Extraction<br>and Editing | Yes | / | Yes | Same | | | Airway Contour Editing | Yes | / | Yes | Same | | | Statistical Analysis | Yes | / | Yes | Same | {13}------------------------------------------------ | Application | Function name | Proposed device<br>uWS-CT | Reference<br>device#2<br>"Philips Plus" CT Scanner<br>(K033326) | Reference device#3<br>nordicICE Software<br>(K090546) | Remark | |-----------------------|---------------------------------|---------------------------|-----------------------------------------------------------------|-------------------------------------------------------|--------| | CT Brain<br>Perfusion | Motion Correction | Yes | Yes | / | Same | | Perfusion | Threshold based<br>segmentation | Yes | Yes | / | Same | | | Select the artery | Yes | Yes | / | Same | | | Vessel Suppression | Yes | Yes | / | Same | | | Calculating parameter map | Yes | / | Yes | Same | | | Time-density curve analysis | Yes | Yes | / | Same | | | Ischemic penumbra analysis | Yes | Yes | / | Same | | | Image fusion | Yes | Yes | / | Same | | | Symmetrical ROI analysis | Yes | Yes | / | Same | | | | Save, Report, Print | Yes | Yes | / | | Application | Function name | Proposed device<br>uWS-CT | Reference device#4<br>3Di including Viewing of<br>Mammography images<br>(K113442) | Remark | |-------------|-----------------------------|---------------------------|-----------------------------------------------------------------------------------|--------| | CT Heart | Multi-Phase Loading | Yes | Yes | Same | | | Heart Chamber Segmentation | Yes | Yes | Same | | | Coronary Artery Extraction | Yes | Yes | Same | | | Editing Tools | Yes | Yes | Same | | | Centerline Extraction | Yes | Yes | Same | | | Stenosis Analysis | Yes | Yes | Same | | | Plaque Analysis | Yes | Yes | Same | | | Cardiac function Assessment | Yes | Yes | Same | | | Save, Report, Print | Yes | Yes | Same | Page 10 of 14 {14}------------------------------------------------ | Application | Function name | Proposed device<br>uWS-CT | Reference device#4<br>3Di including Viewing of<br>Mammography images<br>(K113442) | Remark | |--------------------|----------------------------|---------------------------|-----------------------------------------------------------------------------------|--------| | CT Calcium Scoring | Calcium sites segmentation | Yes | Yes | Same | | | Calculate Calcium score | Yes | Yes | Same | | | Save, Report, Print | Yes | Yes | Same | | Application | Function name | Proposed device<br>uWS-CT | Predicate Device#5<br>syngo.via<br>(K150843) | Remark | |-------------------------------|---------------------|---------------------------|----------------------------------------------|--------| | CT Bone Structure<br>Analysis | Labeling Ribs | Yes | Yes | Same | | | Labeling Spine | Yes | Yes | Same | | | Batch | Yes | Yes | Same | | | Save, Report, Print | Yes | Yes | Same | | Application | Function name | Proposed device<br>uWS-CT | Reference device#6<br>syngo.CT Dynamic Angio<br>(K120331) | Remark | |---------------------|----------------------------------------------|---------------------------|-----------------------------------------------------------|--------| | CT Dynamic Analysis | Motion correction | Yes | Yes | Same | | | Multiple phase viewing | Yes | Yes | Same | | | Bone Removal | Yes | Yes | Same | | | Dynamic CT datasets viewing<br>in 3D/4D mode | Yes | Yes | Same | | | Save, Report, Print | Yes | Yes | Same | {15}------------------------------------------------ | Application | Function name | Proposed device<br>uWS-CT | Reference device#7:<br>syngo.CT Liver Analysis<br>(K133643) | Reference device#8<br>IntelliSpace Portal Platform<br>(K162025) | Remark | |------------------------|---------------------|---------------------------|-------------------------------------------------------------|-----------------------------------------------------------------|--------| | CT Liver<br>Evaluation | Phase Selection | Yes | Yes | / | Same | | | Liver Segmentation | Yes | Yes | / | Same | | | Lesion Segmentation | Yes | Yes | / | Same | | | Vessel Extraction | Yes | Yes | / | Same | | | Vascular Editing | Yes | Yes | / | Same | | | Liver Segments | Yes | / | Yes | Same | | | Virtual Planning | Yes | Yes | / | Same | | | RFA | Yes | / | Yes | Same | | | Measurement | Yes | Yes | / | Same | | | Save, Report, Print | Yes | Yes | / | Same | {16}------------------------------------------------ Image /page/16/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark gray and has a white horizontal line through the middle. The logo is simple and modern in design. #### 9. Performance Data The following performance data were provided in support of the substantial equivalence determination. ## Biocompatibility Not Applicable to the proposed device, because the device is stand-alone software. ## Electrical Safety and Electromagnetic Compatibility (EMC) Not Applicable to the proposed device, because the device is stand-alone software. ## Software Verification and Validation Software verification and validation testing was provided to demonstrate safety and efficacy of the proposed device. This includes a hazard analysis, and the potential hazards have been classified as a moderate level of concern (LOC). Those documentations include: - Software description - Hazard Analysis - · Software requirements specification (SRS) - Software Architecture Description - · Software Development Environment Description - Software Verification and Validation - · Cyber security Documents ## Animal Study No animal study was required. ## Clinical Studies No clinical study was required. ## Performance Verification - Performance Evaluation Report for CT Lung Density Analysis - Performance Evaluation Report for CT Brain Perfusion - Performance Evaluation Report for CT Heart - Performance Evaluation Report for CT Calcium Scoring - . Performance Evaluation Report for CT Dynamic Analysis - Performance Evaluation Report for CT Bone Structure - Performance Evaluation Report for CT Liver Evaluation ## Other Standards and Guidance # Page 13 of 14 {17}------------------------------------------------ Image /page/17/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is dark teal in color and has a white horizontal line running through the middle of it. The overall design is clean and modern. - NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2016). - . ISO 14971 Medical devices - Application of risk management to medical devices (Edition 2.0, corrected version, 2007). - . IEC 62304 Medical device software - Software life cycle processes (Edition 1.1, 2015). ## Summary The features described in this premarket submission are supported with the results of the testing mentioned above; the uWS-CT was found to have a safety and effectiveness profile that is similar to the predicate device and reference devices. ## 10. Substantially Equivalent (SE) Conclusion The proposed device is equivalent to the predicate device with regard to safety and efficacy. This conclusion is based upon a comparison of intended use, technological characteristics, performance specification, device hazards as well as verification and validation results. In…