# K063344: Caas Qca 3D

- Pathway: 510(k) (Special)
- Applicant: Pie Medical Imaging BV
- Decided: Nov 28, 2006 after 22 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 K922804 (1992). 8 ancestors in all.
39 later devices descend from it; 2 cite it directly.
5 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052988: CAAS, Pie Medical Imaging BV (2005) Summary page 1.

## Most influential descendants
- 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
- K083745: The IC-Pro System, Model Version 3.2 (2009), 30 descendants of its own
- K110256: The IC-Pro System (2011), 15 descendants of its own

## Indications for use
Detect the contour of the coronary vessel from a set of angiographic X-ray images - Generate absolute measurements about the dimensions of the coronary arterial segment in 3D space to improve accuracy by elimination of out-of-plane and foreshortening errors.

Source page: https://510kreport.com/device/K063344
Methodology: https://510kreport.com/methodology