{
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  "cite_as": "StrokeSENS ASPECTS Software Application, Circle Cardiovascular Imaging Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/strokesens-aspects-software-application-pok (data as of 2026-11-15).",
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    "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/strokesens-aspects-software-application-pok",
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  },
  "device": {
    "name": "StrokeSENS ASPECTS Software Application",
    "registry_name": "StrokeSENS ASPECTS Software Application",
    "url": "https://devicerts.com/devices/strokesens-aspects-software-application-pok",
    "manufacturer": {
      "name": "Circle Cardiovascular Imaging Inc",
      "url": "https://devicerts.com/manufacturers/circle-cardiovascular-imaging-inc",
      "country": "Canada",
      "country_basis": "FDA 510(k) applicant",
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    ],
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    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The StrokeSENS ASPECTS Software Application is a Computer-Assisted Diagnostic Software for Lesions Suspicious for Cancer, classified under the Radiology specialty. It is designed to assist in the assessment of acute ischemic stroke by quantifying and analyzing perfusion deficits in brain imaging studies, aiding in clinical decision-making for treatment eligibility.\n\nThis software is supplied as a digital application, intended for use in radiology departments within healthcare settings. It operates on a standalone or networked system, requiring no physical sterility or single-use considerations. The device is authorized under FDA 510K, MDD, and MDR regulatory frameworks, with a Class II designation. No MRI safety or physical size specifications are noted in the regulatory data.",
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      "generated_on": "2026-09-18",
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        {
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}