# K180019: CAAS Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Imaging BV
- Decided: May 3, 2018 after 121 days
- Product code: IZI (System, X-Ray, Angiographic)
- 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: 14 generations back to K926514 (1993). 98 ancestors in all.
8 later devices descend from it; 3 cite it directly.
1 of 107 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151780: CAAS Workstation, Pie Medical Imaging BV (2016) Summary page 4.
- K052988: CAAS, Pie Medical Imaging BV (2005) Summary page 4.

## Most influential descendants
- K182611: Qangio XA 3D (2019), 4 descendants of its own
- K210093: AccuFFRangio (2021), 2 descendants of its own
- K232147: CAAS Workstation (2024), 1 descendant of its own
- K251355: X1-FFR (2025), 0 descendants of its own
- 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 and peripheral vessels; • Quantify the motion of the left and right ventricular wall; • Perform density measurements; • Determine C-arm position for optimal imaging of cardiovascular structures; • Enhance stent visualization and measure stent dimensions; • Quantify pressure drop in coronary vessels; • Co-registration of angiographic X-Ray images with IVUS and OCT images. CAAS Workstation is intended to be used by or under supervision of a cardiologist or radiologist.

Source page: https://510kreport.com/device/K180019
Methodology: https://510kreport.com/methodology