# K060941: Caas MRV Version 3.0

- Pathway: 510(k) (Special)
- Applicant: Pie Medical Imaging BV
- Decided: Apr 19, 2006 after 13 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 K940172 (1994). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994283: Mri- Magnetic Resonance Analytical Software System, Medis Medical Imaging Systems BV (2000) Summary page 1.

## Most influential descendants
- K162112: Caas MRV (2016), 2 descendants of its own
- K090155: Caas MR Flow 1.0 (2009), 2 descendants of its own
- K181825: CAAS MR Solutions (2018), 1 descendant of its own
- K232007: CAAS MR Solutions (2024), 0 descendants of its own

## Indications for use
1. Delineate the inner and outer wall of the ventricles automatically, semi-automatically or manually, as well as the papillary muscles, on different kinds of MRI images. 2. Derive from these images and contours quantitative information to be used to assist in cardiac analysis The CAAS MRV has been designed to be used in everyday clinical practice to support clinical diagnoses, as well as for research purposes like clinical research trials.

Source page: https://510kreport.com/device/K060941
Methodology: https://510kreport.com/methodology