# K041682: Caas MRV

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Imaging BV
- Decided: Jul 27, 2004 after 36 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.
1 later device descends from it; 1 cites it directly.
0 of 5 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
- K082510: Image-Arena Applications, Model Image-Arena VA Platform 1.0, 4D LV-Analysis 2.5, 4D LV-Analysis MR 1.0 (2008), 0 descendants of its own

## Indications for use
The CAAS MRV has been designed for quantitative functional analysis of the left and right ventricle of the heart based on multi-slice, multi-phase cine MRI images. Specifically, it enables the user to: 1. Delineate automatically or semi-automatically the inner and outer wall of the ventricles, as well as the papillary muscles, on the MRI images 2. Derive from these contours the global and regional functional parameters like Ejection Fraction, Stroke Volume, Wall Movement etc. The CAAS MRV has been designed to be used in everyday clinical practice, as well as for research purposes like clinical research trials.

Source page: https://510kreport.com/device/K041682
Methodology: https://510kreport.com/methodology