# K113076: Caas a-Valve

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Imaging BV
- Decided: Jan 30, 2012 after 105 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: 12 generations back to K926514 (1993). 96 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 98 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100292: Caas Qva 3D, Caas Qca 3D, Pie Medical Imaging BV (2010) Summary page 1.
- K110256: The IC-Pro System, Paieon, Inc. (2011)

## Most influential descendants
- K143044: CAAS A-Valve (2015), 0 descendants of its own

## Indications for use
CAAS A-Valve has been developed to support the interventionalist during or in preparation of treatment of the aortic root. Based on a set of angiographic X-ray images an analysis is performed: - To assist in C-arm projection selection to optimize visualization during treatment; - To calculate dimensions of the aortic root corrected for out-of-plane magnification and foreshortening errors.

Source page: https://510kreport.com/device/K113076
Methodology: https://510kreport.com/methodology