# K162112: Caas MRV

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Imaging BV
- Decided: Sep 21, 2016 after 54 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: 6 generations back to K940172 (1994). 20 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060941: Caas MRV Version 3.0, Pie Medical Imaging BV (2006) Summary page 4.
- K140587: MR-CT Vva, Medis Medical Imaging Systems BV (2015) Summary page 4.

## Most influential descendants
- K181825: CAAS MR Solutions (2018), 1 descendant of its own
- K232007: CAAS MR Solutions (2024), 0 descendants of its own

## Indications for use
CAAS MRV features segmentation of cardiovascular structures on different types of MR images as well as measurement and reporting tools to facilitate the following use: * Quantitative functional and regional analyses of the heart ventricles * Quantification of T2 and T2* relaxation values CAAS MRV is intended to be used by or under supervision of a cardiologist or radiologist. When the results provided by CAAS MRV are used in a clinical setting to support diagnosis of cardiovascular conditions, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical decision making.

Source page: https://510kreport.com/device/K162112
Methodology: https://510kreport.com/methodology