# K040746: Mra-CMS

- Pathway: 510(k) (Traditional)
- Applicant: Medis Medical Imaging Systems BV
- Decided: Jun 8, 2004 after 77 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: 1 generation back to K002519 (2000). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002519: Vitrea 2, Version 2.1, Vital Images, Inc. (2000) Summary page 1.

## Most influential descendants
- K122164: MR Vessellq Xpress (2012), 0 descendants of its own
- K062386: Qangio CT (2006), 0 descendants of its own

## Indications for use
MRA has been developed for the objective and reproducible analysis of MRA data The intended purposes are: 1. Supporting clinical diagnoses about the status of the global and regional function and anatomy of the human heart; 2. Supporting the subsequent clinical decision making processes; 3. Supporting the use in clinical research trials, directed at studying changes in function and anatomy of the heart chambers as a result of treatment.

Source page: https://510kreport.com/device/K040746
Methodology: https://510kreport.com/methodology