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.

Device Description

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.

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.

AI/ML Overview

This document is a 510(k) summary for the Universal Viewer, a medical image management and processing system developed by GE Healthcare. It states that the device is substantially equivalent to a predicate device (Centricity Universal Viewer K182419). As such, the document primarily focuses on demonstrating substantial equivalence rather than providing detailed acceptance criteria and a study to prove they are met in the same way a de novo device might.

Based on the provided text, here's the information related to acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of quantitative acceptance criteria and reported device performance metrics in the format typically seen for a new device's efficacy study. Instead, it relies on demonstrating that the Universal Viewer operates in a "substantially equivalent" manner to its predicate device, Centricity Universal Viewer (K182419).

The "Comparison" table in the document summarizes the feature/technological comparison between the predicate and proposed device, indicating functional equivalence:

Feature	Predicate Device Centricity Universal Viewer (K182419)	Proposed Device Universal Viewer	Discussion of Differences
Backend Integration	Centricity PACS (K110875) and Enterprise Archive	Enterprise Archive	Substantially Equivalent. Simplified Integration with GE Healthcare's Enterprise Archive (EA) for unified short- and long-term storage for the image and non-image data and study management workflow
Image Display and Review	Yes	Yes	Identical
Image Annotations and measurements	Yes	Yes	Identical
General Workflow including, Exam Search, Exam Assignments, System and Custom Worklists, Reporting Workflow	Available in the UV study list and/or Workflow Manager if enabled	Available in Workflow Manager	Substantially Equivalent. Consolidated to one worklist.

The "Determination of Substantial Equivalence" section states:
"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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a distinct "test set" with a particular sample size or data provenance in terms of patient data. The evaluation appears to be based on design control testing and comparison of functionalities to the predicate device, rather than a clinical study evaluating diagnostic performance on a patient dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical study with explicit ground truth establishment by experts on a patient image test set is described. The evaluation focuses on technological and functional equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical study with a test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The Universal Viewer is described as a medical image display and interpretation software, not an AI-powered diagnostic assist tool that would typically undergo an MRMC study to compare reader performance with and without AI assistance. The document focuses on the system's ability to display and process images, and its substantial equivalence to another such system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a "medical image management and processing system" used by "healthcare professionals" to aid in diagnosis. It is not an autonomous algorithm designed for standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical study directly assessing diagnostic accuracy against a defined ground truth (e.g., pathology, expert consensus) is described. The "ground truth" for this type of submission is the established performance and safety of the predicate device, against which the new device is compared in terms of features and functionality.

8. The sample size for the training set

Not applicable. This document describes a software application for viewing and processing medical images, not an AI/ML model that would require a distinct training set. The development involved "design control testing" rather than model training.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set or ground truth in the context of machine learning.

Summary

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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

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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

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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)

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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 ContactPerson:	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 RegulationNumber:	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:

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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 provides Application Program Interfaces (APIs) to integrate with third-party medical devices and non-medical devices.

Intended Use:

Indications for Use:

Typical users of this system are authorized healthcare professionals.

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.

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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	PredicateDeviceCentricityUniversalViewer(K182419)	Proposed DeviceUniversal Viewer	Discussion of Differences
Backend Integration	Centricity PACS(K110875) andEnterpriseArchive	Enterprise Archive	Substantially Equivalent.Simplified Integration withGE Healthcare's EnterpriseArchive (EA) for unifiedshort- and long-term storagefor the image and non-imagedata and study managementworkflow
Image Display and Review	Yes	Yes	Identical
Image Annotations andmeasurements	Yes	Yes	Identical
General Workflow including,Exam SearchExam AssignmentsSystem and Custom WorklistsReporting Workflow	Available in theUV study listand/or WorkflowManager ifenabled	Available inWorkflow Manager	Substantially Equivalent.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

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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).

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).