# K151780: CAAS Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Imaging BV
- Decided: Mar 11, 2016 after 254 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: 13 generations back to K926514 (1993). 97 ancestors in all.
9 later devices descend from it; 1 cites 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)
- K133993: Caas Workstation, Pie Medical Imaging (2014) Summary page 4.
- K060483: Volcano Angio-Ivus Mapping (Aim) System, Volcano Corporation (2006) Summary page 4.

## Most influential descendants
- 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
- K232147: CAAS Workstation (2024), 1 descendant of its own
- K251355: X1-FFR (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; * 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. When the results provided by CAAS Workstation are used in a clinical setting to support diagnoses and 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/K151780
Methodology: https://510kreport.com/methodology