{
  "format": "devicerts.device.v1",
  "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).",
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    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "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",
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  },
  "device": {
    "name": "CAAS Workstation",
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    "url": "https://devicerts.com/devices/caas-workstation-qha",
    "manufacturer": {
      "name": "Pie Medical Imaging BV",
      "url": "https://devicerts.com/manufacturers/fda-fei-3003595527",
      "country": "Netherlands",
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    ],
    "product_codes": [
      "QHA"
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    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "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.\n\nThis 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)",
      "ai_generated": true,
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      "date": "2024-04-09",
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            {
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            {
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