# K100292: Caas Qva 3D, Caas Qca 3D

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Imaging BV
- Decided: Apr 30, 2010 after 87 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: 11 generations back to K926514 (1993). 66 ancestors in all.
13 later devices descend from it; 2 cite it directly.
1 of 80 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052988: CAAS, Pie Medical Imaging BV (2005) Summary page 1.
- K063344: Caas Qca 3D, Pie Medical Imaging BV (2006) Summary page 1.
- K083745: The IC-Pro System, Model Version 3.2, Paieon, Inc. (2009) Summary page 1.

## Most influential descendants
- K133993: Caas Workstation (2014), 10 descendants of its own
- K151780: CAAS Workstation (2016), 9 descendants of its own
- K180019: CAAS Workstation (2018), 8 descendants of its own
- K182611: Qangio XA 3D (2019), 4 descendants of its own
- K210093: AccuFFRangio (2021), 2 descendants of its own

## Indications for use
CMAS QxA 3D is used for: 1. 3D Reconstruction of coronary arteries and peripheral vessels from a set of angiographic X-ray images; 2. Calculation of dimensions of the vessel corrected for out-of-plane magnification and foreshortening errors; 3. To determine acquisition parameters for optimal imaging of part of interest on a vessel tree; 4. To assist in the positioning of implantable devices in the vessel segment of interest. The CAAS QxA 3D software is designed for use in clinical practice to support diagnoses and interventional treatment of cardiovascular conditions. The software is used by or under supervision of a cardiologist or radiologist. CAAS OCA 3D: coronary arteries CAAS QVA 3D: peripheral vessels

Source page: https://510kreport.com/device/K100292
Methodology: https://510kreport.com/methodology