# K090155: Caas MR Flow 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Imaging BV
- Decided: May 22, 2009 after 120 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: 4 generations back to K940172 (1994). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 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 1.
- K994282: Mri- Flow Analytical Software Package, Medis Medical Imaging Systems BV (2000) Summary page 1.

## 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
1. Delineate the contours of blood in vessels and through heart vales in Phase-Contrast MR images; manually, semi-automatically or automatically, 2. Derive from these images and contours quantitative cardiovascular analysis results. The CAAS MR Flow has been designed to be used in everyday clinical practice to support clinical diagnoses, as well as foi. research purposes like clinical research trials,

Source page: https://510kreport.com/device/K090155
Methodology: https://510kreport.com/methodology