# K012475: Caas II Qva

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Imaging BV
- Decided: Oct 24, 2001 after 83 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 K945540 (1995). 1 ancestor in all.
44 later devices descend from it; 1 cites it directly.
5 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945540: Caas II, Pie Medical Equipment B.V. (1995) Summary page 1.

## Most influential descendants
- K052988: CAAS (2005), 43 descendants of its own
- K063344: Caas Qca 3D (2006), 39 descendants of its own
- K072591: Cardiop-B System, Version 2.1 (2007), 38 descendants of its own
- K073328: Cardiop-B System, Version 2.1 with Lva (2008), 37 descendants of its own
- K082907: IC-Pro System, Version 3.1.0.4 (2008), 36 descendants of its own

## Indications for use
1. Optimizing the quantitation of artery dimensions - to be used in clinical trials and in clinical cath lab environment 2. Managing of data resulting of the analysis of artery dimensions

Source page: https://510kreport.com/device/K012475
Methodology: https://510kreport.com/methodology