# K150420: Centricity Universal Viewer

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: May 26, 2015 after 97 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K942120 (1994). 14 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123174: Centricity Pacs-IW with Universal Viewer, GE Healthcare (2012) Summary page 4.

## Most influential descendants
- K182419: Centricity Universal Viewer (2018), 2 descendants of its own
- K211312: Universal Viewer (2021), 1 descendant of its own
- K253639: View (2026), 0 descendants of its own

## Recalls of this device
- Jan 30, 2026 · Class II · Z-1570-2026: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an 
- Feb 19, 2025 · Class II · Z-1483-2025: There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the ser
- Sep 14, 2023 · Class II · Z-0140-2024: GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal View
- Mar 28, 2023 · Class II · Z-1501-2023: GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.
- Oct 28, 2022 · Class II · Z-0722-2023: There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can re
- Jul 15, 2022 · Class II · Z-1566-2022: Inaccurate Distance and Area measurements with use of Global Stack viewport.
- Aug 6, 2021 · Class II · Z-2503-2021: Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
- Dec 16, 2019 · Class II · Z-0819-2020: Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a pote
- May 17, 2019 · Class II · Z-1886-2019: There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
- May 16, 2019 · Class II · Z-1910-2019: There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.
- Dec 20, 2018 · Class II · Z-0793-2019: When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors may not show images of the patient selected on UV, 
- Oct 11, 2018 · Class II · Z-0375-2019: Synchronization failure
- Aug 30, 2018 · Class II · Z-0195-2019: Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present.
- Jan 25, 2018 · Class II · Z-2102-2018: Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.
- Sep 28, 2015 · Class II · Z-0226-2016: Inaccurate distance measurements with magnified projection X-ray images.

## Indications for use
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.

Source page: https://510kreport.com/device/K150420
Methodology: https://510kreport.com/methodology