# K945540: Caas II

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Equipment B.V.
- Decided: Jun 28, 1995 after 226 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
45 later devices descend from it; 2 cite 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K012475: Caas II Qva (2001), 44 descendants of its own
- 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

Source page: https://510kreport.com/device/K945540
Methodology: https://510kreport.com/methodology