{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Lunit Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/lunit-inc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/lunit-inc",
    "json_url": "https://devicerts.com/manufacturers/lunit-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/lunit-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA registration and listing",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm"
      }
    ],
    "eudamed_record_synced": "2026-11-07",
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-15",
    "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/manufacturers/lunit-inc",
    "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."
  },
  "manufacturer": {
    "name": "Lunit Inc.",
    "url": "https://devicerts.com/manufacturers/lunit-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "South Korea",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "KR-MF-000005200"
      },
      {
        "label": "FDA FEI",
        "value": "3021230777"
      },
      {
        "label": "DUNS",
        "value": "690102406"
      }
    ],
    "summary": "Lunit Inc. is a medical device manufacturer based in South Korea, with 11 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (FDA Class II; EU Class IIa) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 11,
    "devices_note": null,
    "certificates": 1,
    "fda_recalls_matched_by_name": 0,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "EUDAMED",
        "devices": 5
      },
      {
        "registry": "FDA GUDID",
        "devices": 5
      },
      {
        "registry": "FDA 510(k)",
        "devices": 4
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 6
      },
      {
        "class": "EU Class IIa",
        "devices": 5
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Z11",
        "name": "Bioimaging and radiotherapy instruments",
        "url": "https://devicerts.com/categories/emdn/Z11",
        "devices": 5
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": [
      {
        "name": "Obelis S.A.",
        "url": "https://devicerts.com/representatives/obelis-sa-be-ar-000000106",
        "country": "Belgium"
      }
    ]
  },
  "devices": {
    "shown": 11,
    "total": 11,
    "all_devices_url": "https://devicerts.com/manufacturers/lunit-inc",
    "items": [
      {
        "name": "Lunit INSIGHT CXR Triage 1.0",
        "url": "https://devicerts.com/devices/lunit-insight-cxr-triage-1-0-bb1af085",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lunit INSIGHT CXR Triage 1.0",
        "url": "https://devicerts.com/devices/lunit-insight-cxr-triage-1-0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lunit INSIGHT MMG (v1.1.10)",
        "url": "https://devicerts.com/devices/lunit-insight-mmg-v1-1-10-qdq",
        "model_reference": "K260320",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2026-04-23",
        "open_recall": false
      },
      {
        "name": "Lunit INSIGHT DBT (V1.2)",
        "url": "https://devicerts.com/devices/lunit-insight-dbt-v1-2-qdq",
        "model_reference": "K253796",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2026-03-26",
        "open_recall": false
      },
      {
        "name": "Lunit INSIGHT CXR Triage",
        "url": "https://devicerts.com/devices/lunit-insight-cxr-triage-qfm",
        "model_reference": "K211733",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "No data",
        "decision_date": "2021-11-10",
        "open_recall": false
      },
      {
        "name": "Lunit INSIGHT DBT v1.1",
        "url": "https://devicerts.com/devices/lunit-insight-dbt-v1-1-qdq",
        "model_reference": "K242652",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2024-10-04",
        "open_recall": false
      },
      {
        "name": "Lunit INSIGHT MMG",
        "url": "https://devicerts.com/devices/lunit-insight-mmg-124012",
        "model_reference": "124012",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lunit INSIGHT CXR",
        "url": "https://devicerts.com/devices/lunit-insight-cxr-113212",
        "model_reference": "113212",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lunit INSIGHT CXR",
        "url": "https://devicerts.com/devices/lunit-insight-cxr-113012",
        "model_reference": "113012",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": "2021-11-10",
        "open_recall": false
      },
      {
        "name": "Lunit INSIGHT DBT",
        "url": "https://devicerts.com/devices/lunit-insight-dbt-126012-ae1ef5a0",
        "model_reference": "126012",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lunit INSIGHT DBT",
        "url": "https://devicerts.com/devices/lunit-insight-dbt-126012",
        "model_reference": "126012",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [
    {
      "number": "MDR 731765",
      "type": "Quality management system",
      "legislation": "MDR",
      "notified_body": "BSI Group The Netherlands B.V.",
      "issued": "2025-09-04",
      "expires": "2027-10-30",
      "status": "amended",
      "no_longer_listed": false
    }
  ],
  "recalls": []
}