Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed.

Typical users of this system are authorized healthcare professionals.

Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.

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.

Contraindications:

Centricity Universal Viewer is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.

Device Description

Centricity Universal Viewer is an Internet based medical image display and interpretation software product that is part of a picture archiving and communications system that assists radiologists and cardiologists in their diagnostic workflows. It provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms).

Centricity Universal Viewer provides APIs (Application Program Interfaces) to integrate with third-party medical devices and non-medical devices, which include integration with Tomtec-Arena™(K132544) for advanced cardiology applications.

Centricity 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 Angioaraphy (XA), Diaital 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.

Centricity Universal Viewer is not intended for the diagnosis of digital pathology images.

Centricity Universal Viewer is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms and operating systems.

The system does not produce any original medical images. All images located on the Centricity Universal Viewer have been received from DICOM compliant modalities and/or image acquisition systems.

AI/ML Overview

The provided text is a 510(k) Summary for the GE Healthcare Centricity Universal Viewer. This document demonstrates substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested sections about acceptance criteria, study details, ground truth, and expert involvement are not applicable or cannot be extracted from this type of regulatory submission.

However, I can provide information based on what is available in the document:

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

This document does not describe specific numerical acceptance criteria or performance metrics for the Centricity Universal Viewer in the way one would find in a clinical performance study for an AI algorithm. Instead, it focuses on software verification and validation activities to ensure functional equivalence to a predicate device.

Acceptance Criteria Category	Reported Device Performance (as described in the document)
Functional Equivalence	Demonstrated functional equivalence to predicate device (Centricity PACS-IW with Universal Viewer K123174) with specified modifications.
Software Quality Assurance	Complies with voluntary standards; applied quality assurance measures including Risk Analysis, Requirements Reviews, Design Reviews, Usability Analysis, Testing (unit, integration, performance, regression, system), and Simulated use testing (Validation).
Safety and Effectiveness	Information provided supports the device to be as safe, as effective and substantially equivalent to its predicate device.
Compliance	Software documentation provided at a moderate level of concern following FDA guidance.

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 "test set" in the context of a clinical performance study with patient data. The testing mentioned (unit, integration, system, simulated use) refers to software engineering verification and validation activities. Therefore, details about sample size, data provenance, or retrospective/prospective nature are not available.

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. The document describes software verification and validation, not a clinical study where ground truth would be established by experts.

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

Not applicable. The document describes software verification and validation, not a clinical study requiring ground truth adjudication.

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

No MRMC comparative effectiveness study is mentioned in this document. The device is a Picture Archiving and Communication System (PACS) viewer, not an AI-assisted diagnostic tool in the sense of providing specific interpretive recommendations. Its purpose is to display and process images for human interpretation.

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

This is not an AI algorithm acting in a standalone capacity. It is an image display and processing system intended for human-in-the-loop diagnostic interpretation.

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

Not applicable. Ground truth in the context of clinical performance evaluation is not discussed. Software validation focused on ensuring the system performs as designed and intended.

8. The sample size for the training set

Not applicable. This document describes a PACS viewer, not a machine learning or AI algorithm that requires a "training set" of data in the common sense.

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

Not applicable, as there is no "training set" referenced for an AI/ML algorithm within this document.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 26, 2015

GE Healthcare % Ms. Cheryl Bork Regulatory Affairs Manager 540 W. Northwest Highway BARRINGTON IL 60010

Re: K150420

Trade/Device Name: Centricity Universal Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 13, 2015 Received: April 15, 2015

Dear Ms. Bork:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150420

Device Name

Centricity Universal Viewer

Indications for Use (Describe)

Typical users of this system are authorized healthcare professionals.

Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.

Contraindications:

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

l. SUBMITTER

GE Healthcare 540 West Northwest Highway Barrington, IL 60010

Primary Contact Person:	Cheryl Bork
	Regulatory Affairs Manager
	GE Healthcare
	Phone: 847-277-6038
	Fax: 847-277-5240

Secondary Contact Person:	Jason MaRegulatory AffairsGE HealthcarePhone: 847-277-4325Fax: 847-277-5240
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Date Prepared: May 21, 2015

II. DEVICE

Name of Device:	Centricity Universal Viewer
Common Name:	Picture Archiving and Communication System
Classification Name:	21 CFR 892.2050, System, Image Processing,Radiological
Regulatory Class:	II
Product Code:	LLZ

III. PREDICATE DEVICE

K123174 - GE Healthcare Centricity PACS-IW with Universal Viewer This predicate device was subject to ONE design-related recall in Oct-13-2013. However, this performance issue has been reviewed and mitigated. A detailed description can be found in Section 21. Total Product Life Cycle (TPLC).

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IV. DEVICE DESCRIPTION

Centricity Universal Viewer is not intended for the diagnosis of digital pathology images.

The system does not produce any original medical images. All images located on the Centricity Universal Viewer have been received from DICOM compliant modalities and/or image acquisition systems.

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V. INDICATIONS FOR USE

Tvpical users of this svstem are authorized healthcare professionals.

Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.

Contraindications:

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Centricity Universal Viewer device emplovs the same fundamental scientific technology as its predicate device, Centricity PACS-IW with Universal Viewer cleared under K123174, with the following modifications:

. Expanding the capabilities of Centricity Universal Viewer for Cardiology in addition to Radiology applications.
. Modified viewer to present a common unified workspace for radiologists, cardiologists and clinicians to perform the review, manipulation and diagnostic interpretation of images and other information generated by acquisition.
. Hardware specifications minimum specifications were modified as a result of technology advancements and obsolescence issues.

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VII. PERFORMANCE DATA

Summary of Non-Clinical Tests

The software documentation was provided at a moderate level of concern following the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

Centricity Universal Viewer complies with voluntary standards as detailed in this premarket notification submission.

The following quality assurance measures were applied to the development of the system:

· Risk Analysis
Requirements Reviews
Design Reviews
Usabilitv Analvsis
Testing on unit level (Verification)
· Integration testing (Verification)
Performance testing (Verification)
· Regression testing (Verification)
· System testing (Verification)
· Simulated use testing (Validation)

The subject of this submission, Centricity Universal Viewer, did not require animal testing, biological testing, sterility testing, electrical safety testing or electromagnetic compatibility testing.

VIII. CONCLUSION

Comparison of the Intended Uses / Indications for Use, the technological characteristics, and performance specifications demonstrate the functional equivalence of the subject device to the predicate device.

Verification and Validation testing results demonstrate that no adverse effects have been introduced by these differences.

The Centricity Universal Viewer device will continue to have an intended use and functionality fitting within the definition of 21 CFR 892.2050, Picture Archiving and Communication Systems, Product Code LLZ.

Information provided in this premarket notification submission supports the Centricity Universal Viewer medical device to be as safe, as effective and substantially equivalent to its predicate device.

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).