# K972215: Medimage

- Pathway: 510(k) (Traditional)
- Applicant: Vepro - Computersysteme GmbH
- Decided: Nov 19, 1997 after 159 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: 1 generation back to K880690 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880690: Siemens Pacs/I-a, Siemens Gammasonics, Inc. (1988) Summary page 1.

## Indications for use
MEDImage will be used to acquire, display, process, archive, retrieve, and transmit diagnostic medical images and information about these images in a single user or network environment. The typical users are trained medical professionals.

Source page: https://510kreport.com/device/K972215
Methodology: https://510kreport.com/methodology