{
  "format": "devicerts.device.v1",
  "cite_as": "Rapid ASPECTS (v3), iSchemaView, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/rapid-aspects-v3-pok (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/rapid-aspects-v3-pok",
    "json_url": "https://devicerts.com/devices/rapid-aspects-v3-pok.json",
    "markdown_url": "https://devicerts.com/devices/rapid-aspects-v3-pok.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
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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/rapid-aspects-v3-pok",
    "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": "Rapid ASPECTS (v3)",
    "registry_name": "Rapid ASPECTS (v3)",
    "url": "https://devicerts.com/devices/rapid-aspects-v3-pok",
    "manufacturer": {
      "name": "iSchemaView, Inc.",
      "url": "https://devicerts.com/manufacturers/ischemaview-inc",
      "country": "United States",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
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        "values": [
          {
            "value": "K232156",
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          }
        ]
      }
    ],
    "product_codes": [
      "POK"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "Rapid ASPECTS (v3) is a computer-assisted diagnostic software tool designed to assist clinicians in evaluating brain CT images for early ischemic stroke. The software automatically analyzes specific brain regions to generate an ASPECT score, which helps characterize ischemic damage by providing standardized, AI-derived scores and annotated images.\n\nThis Class II medical device is categorized under radiology and is regulated under FDA 510(k) clearance K232156. It is intended for use by radiologists to facilitate accurate and consistent stroke assessment.",
      "ai_generated": true,
      "generated_on": "2026-09-27",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
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  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K232156",
      "number_label": null,
      "device_udi_di": null,
      "date": "2024-01-19",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
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      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
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              "value": "K232156",
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            }
          ]
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        {
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        {
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}