# K182419: Centricity Universal Viewer

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Dec 14, 2018 after 100 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K942120 (1994). 15 ancestors in all.
2 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)
- K150420: Centricity Universal Viewer, GE Healthcare (2015) Summary page 5.

## Most influential descendants
- 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-1569-2026: 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 8, 2023 · Class II · Z-0142-2024: When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different pati
- Jul 15, 2022 · Class II · Z-1566-2022: Inaccurate Distance and Area measurements with use of Global Stack viewport.
- Aug 12, 2021 · Class II · Z-0012-2022: A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutr
- Mar 19, 2021 · Class II · Z-1533-2021: When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager option is used as the PACS worklist launching the viewer, the patient jacket may potentially
- 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 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.

## 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/K182419
Methodology: https://510kreport.com/methodology