{
  "format": "devicerts.device.v1",
  "cite_as": "Deep Learning Image Reconstruction, GE Healthcare Japan Corporation. deviCERTS medical device catalogue. https://devicerts.com/devices/deep-learning-image-reconstruction-5869275 (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/deep-learning-image-reconstruction-5869275",
    "json_url": "https://devicerts.com/devices/deep-learning-image-reconstruction-5869275.json",
    "markdown_url": "https://devicerts.com/devices/deep-learning-image-reconstruction-5869275.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
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    "registry_records_last_synced": "2026-10-24",
    "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/deep-learning-image-reconstruction-5869275",
    "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": "Deep Learning Image Reconstruction",
    "registry_name": "Deep Learning Image Reconstruction",
    "url": "https://devicerts.com/devices/deep-learning-image-reconstruction-5869275",
    "manufacturer": {
      "name": "GE Healthcare Japan Corporation",
      "url": "https://devicerts.com/manufacturers/fda-fei-3002808529",
      "country": "Japan",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union and United States"
    },
    "classification": [
      {
        "class": "Class IIa",
        "system": "EU MDR"
      },
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "Catalogue number",
        "values": [
          {
            "value": "5869275",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          },
          {
            "value": "5928863",
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      {
        "label": "Primary DI / UDI-DI",
        "values": [
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          {
            "value": "00195278620453",
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              "FDA GUDID (AccessGUDID)"
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      },
      {
        "label": "Basic UDI-DI",
        "values": [
          {
            "value": "8406821BUG00032GR",
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      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K193170",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          },
          {
            "value": "K212067",
            "registries": [
              "FDA GUDID (AccessGUDID)"
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          },
          {
            "value": "K220961",
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          },
          {
            "value": "K230807",
            "registries": [
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            ]
          }
        ]
      }
    ],
    "product_codes": [
      "JAK"
    ],
    "emdn": [
      {
        "code": "Z11030692",
        "term": "COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE"
      },
      {
        "code": "Z11030682",
        "term": "COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES"
      }
    ],
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        "code": "40867",
        "term": "CT system application software"
      }
    ],
    "description": {
      "text": "The Deep Learning Image Reconstruction is a radiological image processing system (Nomenclature Code: Z11030692) designed to enhance computed tomography (CT) and CT angiography (CTA) image quality through deep learning algorithms. It processes raw scan data to generate sharper, clearer images with reduced noise while preserving anatomical details, improving diagnostic confidence and workflow efficiency.\n\nThis software-based solution is non-sterile, non-reusable, and non-implantable, intended for use with compatible CT systems. Supplied as a digital application, it requires no reprocessing or sterilization and is classified as Class IIa under FDA 510(k) clearance (Reference: 5869275, K230807). Compliance with MDR regulations is also noted. The device operates in radiology settings and is assigned a Basic UDI: 8406821BUG00032GR for traceability.",
      "ai_generated": true,
      "generated_on": "2026-09-18",
      "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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  },
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      "type": "CE/MDR",
      "number": "8406821BUG00032GR",
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      "device_udi_di": null,
      "date": "2023-10-28",
      "date_kind": "registered",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
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      "number": "K230807",
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      "device_udi_di": null,
      "date": "2023-04-20",
      "date_kind": "issued",
      "decision_code": null,
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      "withdrawn": null,
      "status": "Active",
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      "derived_from_gudid": false
    },
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K220961",
      "number_label": null,
      "device_udi_di": null,
      "date": "2022-07-29",
      "date_kind": "issued",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K212067",
      "number_label": null,
      "device_udi_di": null,
      "date": "2021-09-17",
      "date_kind": "issued",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "00195278303202",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2021-08-25",
      "date_kind": "listed",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Listed",
      "status_note": "GUDID: in commercial distribution",
      "derived_from_gudid": false
    },
    {
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      "number": "K193170",
      "number_label": null,
      "device_udi_di": null,
      "date": "2019-12-13",
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    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
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