# K143044: CAAS A-Valve

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Imaging BV
- Decided: Feb 6, 2015 after 107 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: 13 generations back to K926514 (1993). 97 ancestors in all.
No later device cites it as a predicate yet.
1 of 98 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113076: Caas a-Valve, Pie Medical Imaging BV (2012) Summary page 4.
- K052988: CAAS, Pie Medical Imaging BV (2005) Summary page 4.

## 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 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; To provide an objective and reproducible grading method for aortic regurgitation based on time versus density curves extracted from an aortogram. The software is used by or under supervision of a cardiologist or radiologist. When the results provided by CAAS A-Valve are used in a clinical setting to support diagnoses or for assistance during intervention of cardiovascular conditions, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical decision making.

Source page: https://510kreport.com/device/K143044
Methodology: https://510kreport.com/methodology