# K253639: View

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Jan 8, 2026 after 50 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K942120 (1994). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211312: Universal Viewer, GE Healthcare (2021) Summary page 5.

## Indications for use
View is a software application that displays, processes, and analyzes medical image data and associated clinical reports to aid in diagnosis for healthcare professionals. It streamlines standard and advanced medical imaging analysis by providing a complete suite of measurement tools intended to generate relevant findings automatically collected for export and save purposes. 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 View.

Source page: https://510kreport.com/device/K253639
Methodology: https://510kreport.com/methodology