← Back to catalogue

CAAS Workstation

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K232147

by Pie Medical Imaging BV

Identifiers

510(k) Number
K232147 FDA 510(k)
FDA Product Code
QHA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1600 FDA 510(k)
Regulation Number
892.1600 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

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)

Frequently asked questions

What clinical applications does the CAAS Workstation support in a cathlab setting?

The CAAS Workstation is designed for coronary and peripheral artery quantification, allowing precise measurement of vessel dimensions. It also enables detailed left and right ventricular heart analysis, stent visualization, and virtual Fractional Flow Reserve (vFFR) calculations—key tools for assessing coronary artery disease and planning interventions. Additionally, it integrates angiography with intravascular imaging modalities like IVUS and OCT pullbacks for enhanced diagnostic accuracy.

How is the CAAS Workstation supplied, and what imaging standards does it use?

The CAAS Workstation is supplied as a standalone workstation solution, meaning it is pre-configured and ready for immediate use in cathlab or research environments. It integrates seamlessly with DICOM-compliant imaging systems, ensuring compatibility with existing X-ray angiographic equipment for coronary and peripheral vascular analysis.

Is the CAAS Workstation intended for single-use or repeated use in clinical settings?

The CAAS Workstation is a software-based device installed on a dedicated workstation, meaning it is intended for repeated use in clinical and research settings. Unlike consumable devices, it does not require replacement after each procedure but may require periodic software updates or maintenance as specified by the manufacturer.

What regulatory pathways has the CAAS Workstation undergone, and where is it authorized?

The CAAS Workstation has undergone FDA 510(k) clearance (K232147) under the Traditional pathway, classified as a Class II device, and is authorized under the Medical Device Directive (MDD) in Europe. It holds multiple European registration numbers (e.g., 9710122, 9614587) and is recognized for use in radiology applications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Caas Workstation - Pie Medical Imaging, Pie Medical Imaging - Solutions in cardiovascular analysis, PDF CAAS Workstation DICOM Conformance Statement - medical.canon

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Pie Medical Imaging BV

Sources (2)

  • FDA 510(k) K232147 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 29, 2026