Universal Viewer

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & 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. May 21, 2021 GE Healthcare c/o Mr. John Braam Regulatory Affairs Leader 500 W. Monroe Street CHICAGO IL 60661-3671 Re: K211312 Trade/Device Name: Universal Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: LLZ Dated: April 29, 2021 Received: April 30, 2021 Dear Mr. John Braam: We have reviewed vour 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 {1}------------------------------------------------ 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) 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) #### K211312 Device Name Universal Viewer #### Indications for Use (Describe) Inutersal Viewer is a software application that displays medical image data and associated clinical reports to aid in diagnosis for healthcare professionals. It performs operations relating to the transfer, storage, display and measurement of image data. Typical users of this system are authorized healthcare professionals. Mammography images may only be interpreted using a monitor compliant with regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies. Lossy compressed mammographic images and digitized film screen images should not be reviewed for primary image interpretations with use of the Universal Viewer. 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized monogram. The monogram is encircled by a blue ring with wave-like patterns on the inner and outer edges. The logo is simple and recognizable. # 510(k) Summary K211312 In accordance with 21 CFR 807.92 the following summary of information is provided: | Date: | April 29, 2021 | |-------------------------------|------------------------------------------------------------------| | Submitter: | GE Healthcare | | | Establishment Registration Number - 3004526608 | | | 500 W. Monroe Street | | | Chicago, IL 60661 | | Primary Contact Person: | John Braam | | | Regulatory Affairs Leader | | | Tel: 262-347-8240 | | | Email: john.braam@ge.com | | Secondary Contact<br>Person: | Elizabeth Mathew | | | Senior Regulatory Affairs Manager | | | Tel: 262-424-7774 | | | Email: Elizabeth.Mathew@ge.com | | Device Trade Name: | Universal Viewer | | Common/Usual Name: | UV | | Proposed Device: | Universal Viewer | | Primary Regulation<br>Number: | 21 CFR 892.2050 – Medical Image Management and Processing System | | Primary Product Code: | LLZ | | Regulatory Class: | Class II | | Predicate Device: | Centricity Universal Viewer | | 510(k) number | K182419 | | Regulation Number: | 21CFR 892.2050 – Picture Archiving and Communications System | | Product Code: | LLZ | | Regulatory Class: | Class II | | Manufacturer: | GE Healthcare | | | 500 W. Monroe Street, | | | Chicago, IL - 60661 | | | USA | ### iption: Universal Viewer is an Internet based medical image display and interpretation software product that is part of a medical image management and processing system. It provides users with capabilities relating to the acceptance, transfer, display, and digital processing of medical images. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. There are decorative swirls around the circle, giving it a classic and recognizable appearance. The Universal Viewer product does not produce any original medical images displayed by Universal Viewer have been received from DICOM compliant modalities and/or image acquisition systems. Universal Viewer supports DICOM SOP classes to access and manage medical imaging studies from Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Nuclear Medicine (NM), Computerized Radiography (CR), Digital mammography (MG), Digital X-ray (DX), Positron Emission Tomography (PET/PT), X-Ray Angiography (XA), Digital Intra-oral X-Ray (IO), Radiofluoroscopic X-ray (RF), Secondary Capture Images (SC), Visible Light (VL) Endoscopic, Microscopic and Photographic Image Storage, Slide Coordinates Microscopic Image Storage, Presentation States (PS), Key Image Notes (KIN), and other DICOM imaging modalities. Universal Viewer provides image manipulation tools to enable users to view and compare images such as: measurements (linear distances, angles, areas, SUV, etc.), annotations (outline and label regions of interest, label spinal vertebrae), MPR, MIP, and 3D image fusion of CT, PET and registration of CT, PET and MR. Universal Viewer is designed to be deployed over conventional Transmission Control Protocol/Internet Protocol (TCP/IP) networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms and operating systems. Universal Viewer provides Application Program Interfaces (APIs) to integrate with third-party medical devices and non-medical devices. # Intended Use: Universal Viewer is a software application that displays medical image data and associated clinical reports to aid in diagnosis for healthcare professionals. It performs operations relating to the transfer, storage, display, and measurement of image data. ### Indications for Use: Universal Viewer is a software application that displays medical image data and associated clinical reports to aid in diagnosis for healthcare professionals. It performs operations relating to the transfer, storage, display, and measurement of image data. Typical users of this system are authorized healthcare professionals. Mammography images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies. Lossy compressed mammographic images and digitized film screen images should not be reviewed for primary image interpretations with use of the Universal Viewer. # Technology: The subject device Universal Viewer employs the same fundamental scientific technology as its predicate device. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized monogram, surrounded by a circular border with wave-like elements. The logo is presented in a blue color scheme. # Comparison: The table below summarizes the feature/technological comparison between the predicate device and the proposed device: | Feature | Predicate<br>Device<br>Centricity<br>Universal<br>Viewer<br>(K182419) | Proposed Device<br>Universal Viewer | Discussion of Differences | |---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Backend Integration | Centricity PACS<br>(K110875) and<br>Enterprise<br>Archive | Enterprise Archive | Substantially Equivalent.<br>Simplified Integration with<br>GE Healthcare's Enterprise<br>Archive (EA) for unified<br>short- and long-term storage<br>for the image and non-image<br>data and study management<br>workflow | | Image Display and Review | Yes | Yes | Identical | | Image Annotations and<br>measurements | Yes | Yes | Identical | | General Workflow including,<br>Exam Search<br>Exam Assignments<br>System and Custom Worklists<br>Reporting Workflow | Available in the<br>UV study list<br>and/or Workflow<br>Manager if<br>enabled | Available in<br>Workflow Manager | Substantially Equivalent.<br>Consolidated to one worklist. | ## Determination of Substantial Equivalence: Summary of Non-Clinical, Design Control Testing: The Universal Viewer device has successfully completed the required design control testing per GE's quality system. Universal Viewer was designed and manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. The following quality assurance measures were applied to the development of the system: - Risk Analysis - Requirements Reviews {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a circular frame. The frame has four stylized water droplets or swirls positioned around the circle, one in each quadrant. The color of the logo is a light blue. - Design Reviews - Performance testing (Verification, validation) - Safety testing (Verification) The testing and results did not raise new questions of safety and effectiveness from those associated with predicate device and demonstrated that the Universal Viewer device performs substantially equivalent to the predicate device. The substantial equivalence determination is also based on the software documentation for a MODERATE level of concern device. # Conclusion: Based on the development under our quality system, and the engineering testing provided, GE Healthcare believes that Universal Viewer is as safe and performs in a substantially equivalent manner to the predicate device Centricity Universal Viewer (K182419).