{
  "format": "devicerts.device.v1",
  "cite_as": "Arterys MICA, Arterys Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/arterys-mica-qih (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/arterys-mica-qih",
    "json_url": "https://devicerts.com/devices/arterys-mica-qih.json",
    "markdown_url": "https://devicerts.com/devices/arterys-mica-qih.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "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/arterys-mica-qih",
    "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": "Arterys MICA",
    "registry_name": "Arterys MICA",
    "url": "https://devicerts.com/devices/arterys-mica-qih",
    "manufacturer": {
      "name": "Arterys Inc.",
      "url": "https://devicerts.com/manufacturers/arterys-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": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K192437",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "QIH"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Arterys MICA is a cloud-based medical imaging analysis platform designed for radiologists and clinicians. It leverages artificial intelligence to process and analyze complex medical images from modalities such as CT and MRI, enhancing diagnostic capabilities with automated analytics and visualization tools.\n\nSupplied as a web-based software solution, Arterys MICA is intended for use in clinical settings where radiologists and imaging specialists review diagnostic images. The platform is not a single-use or reusable physical device but a software application requiring internet connectivity and cloud infrastructure. It holds FDA 510(k) clearance under the product code QIH, with no explicit mention of sterility, MRI safety, or physical size specifications in the provided data.",
      "ai_generated": true,
      "generated_on": "2026-09-19",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K192437",
      "number_label": null,
      "device_udi_di": null,
      "date": "2020-03-25",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K192437",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "QIH",
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      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
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            {
              "value": "Class II",
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            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 892.2050",
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            }
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        {
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            {
              "value": "Radiology",
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            }
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    }
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}