# K232147: CAAS Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Imaging BV
- Decided: Apr 9, 2024 after 265 days
- Product code: QHA (X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device)
- 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
Longest line of descent: 15 generations back to K926514 (1993). 99 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 101 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180019: CAAS Workstation, Pie Medical Imaging BV (2018) Summary page 4.

## Most influential descendants
- K243632: uWS-Angio Basic (2025), 0 descendants of its own

## Indications for use
CAAS Workstation features segmentation of cardiovascular structures, 3D reconstruction of vessel segments and catheter path based on multiple angiographic images, measurement and reporting tools to facilitate the following use: • Calculate the dimensions of cardiovascular structures; • Quantify stenosis in coronary vessels; • Determine C-arm position for optimal imaging of cardiovascular structures; • Quantify pressure drop in coronary vessels; • Enhance stent visualization and measure stent dimensions; CAAS Workstation is intended to be used by or under supervision of a cardiologist or radiologist.

Source page: https://510kreport.com/device/K232147
Methodology: https://510kreport.com/methodology