{
  "format": "devicerts.device.v1",
  "cite_as": "CAAS II QVA, Pie Medical Imaging BV. deviCERTS medical device catalogue. https://devicerts.com/devices/caas-ii-qva-llz (data as of 2026-11-15).",
  "source": {
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    "publisher": "deviCERTS (devicerts.com)",
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    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "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-ii-qva-llz",
    "disclaimer": "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."
  },
  "device": {
    "name": "CAAS II QVA",
    "registry_name": "CAAS II QVA",
    "url": "https://devicerts.com/devices/caas-ii-qva-llz",
    "manufacturer": {
      "name": "Pie Medical Imaging BV",
      "url": "https://devicerts.com/manufacturers/fda-fei-3003595527",
      "country": "Netherlands",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
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      "label": "Active",
      "detail": "United States"
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    "classification": [
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        "system": "US FDA"
      }
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        "values": [
          {
            "value": "K012475",
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    ],
    "product_codes": [
      "LLZ"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The CAAS II QVA is a software application designed for quantitative vascular analysis, focusing on peripheral vessels such as the abdominal aorta, carotid, renal, iliac, and femoral arteries. It provides single vessel analysis with features like calibration, contour detection, and quantification of stenosis severity to support diagnosis and treatment selection.\n\nThe device is supplied as a workstation and is intended for use in clinical and research settings. It is not specified as single-use or reusable, and no specific storage conditions are provided. The CAAS II QVA is FDA 510(k) cleared and adheres to internationally accepted standards.",
      "ai_generated": true,
      "generated_on": "2026-09-22",
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      "region": "United States",
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      "number": "K012475",
      "number_label": null,
      "device_udi_di": null,
      "date": "2001-10-24",
      "date_kind": "decision",
      "decision_code": "SESE",
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      "withdrawn": null,
      "status": "Active",
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    }
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  "properties": [
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            {
              "value": "K012475",
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}