# K243651: VersaViewer

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Apr 21, 2025 after 146 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: 3 generations back to K871859 (1987). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041521: Volume Viewer Plus, General Electric Medical Systems (2004) Summary page 6.

## Indications for use
VersaViewer is a medical diagnosis software supporting 2D, 3D and 4D medical images series for their processing and analysis through customizable layouts allowing multimodality review. It streamlines standard and advanced medical imaging analysis by providing a suite of measurements capabilities. It is designed for use by trained healthcare professionals and is intended to assist the physician in diagnosis, who is responsible for making all final patient management decisions. VersaViewer is not intended for the displaying of digital mammography images for diagnosis.

Source page: https://510kreport.com/device/K243651
Methodology: https://510kreport.com/methodology