# K211312: Universal Viewer

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: May 21, 2021 after 21 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K942120 (1994). 16 ancestors in all.
1 later device descends 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)
- K182419: Centricity Universal Viewer, GE Healthcare (2018) Summary page 4.

## Most influential descendants
- K253639: View (2026), 0 descendants of its own

## Recalls of this device
- Sep 8, 2023 · Class II · Z-0143-2024: 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.

## 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.

Source page: https://510kreport.com/device/K211312
Methodology: https://510kreport.com/methodology