# K120207: VISIA

- Pathway: 510(k) (Traditional)
- Applicant: MeVis Medical Solutions AG
- Decided: Apr 23, 2012 after 90 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 K913770 (1991). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071331: Vitrea Version 4.0, Vital Images, Inc. (2007) Summary page 2.

## Indications for use
VisaTM is a medical image processing software application intended for the visualization of images from various sources (e.g., Computed Tomography (CT), Magnetic Resonance (MR), etc). The system provides viewing, quantification, manipulation, communication, and printing of medical images. Visiam is not meant for primary diagnostic interpretation of mammography.

Source page: https://510kreport.com/device/K120207
Methodology: https://510kreport.com/methodology