# CAAS Workstation

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/caas-workstation-qha>
- Manufacturer: [Pie Medical Imaging BV](https://devicerts.com/manufacturers/fda-fei-3003595527) (Netherlands)
- Device class: Class II (US FDA)
- FDA product code: QHA

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The CAAS Workstation is an X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device, designed for coronary and peripheral artery quantification, left and right ventricular heart analysis, and stent visualization. It also performs virtual Fractional Flow Reserve (vFFR) calculations and co-registers angiography with intravascular ultrasound (IVUS) and optical coherence tomography (OCT) pullbacks.

This software is used in cathlab and research settings, featuring a flexible graphical user interface (GUI) layout. Supplied as a standalone workstation solution, it adheres to DICOM standards for imaging integration. The device is classified as Class II under FDA regulations and is authorized under the Medical Device Directive (MDD) with FDA 510(k) clearance (K232147) and European registration numbers (9710122, 9614587, 3038136528, 3017654247)

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K232147 · decision 2024-04-09 · decision SESE · status: Active
- **EUDAMED** · CE/MDD · European Union · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K232147 [FDA 510(k)]
- FDA product code: QHA [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.1600 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: CAAS Workstation, Pie Medical Imaging BV. deviCERTS medical device catalogue. https://devicerts.com/devices/caas-workstation-qha (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-06
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/caas-workstation-qha.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/caas-workstation-qha
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.