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CAAS Workstation

by Pie Medical Imaging BV 3 variants

510(k) K232147

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232147↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK232147 Date9 Apr 2024ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K232147 decided 9 Apr 2024 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
QHA
Device class
Class II
Regulation
21 CFR Part 892.1600
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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)

Devices cleared under K232147

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K232147
UDI-DISize and differences
CAAS Workstation 9.2
Pie Medical Imaging B.V.
9.208056304455772 —On the market

Similar devices

Other devices filed under FDA product code QHA (X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device).

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