{
  "format": "devicerts.device.v1",
  "cite_as": "GC85A Digital Diagnostic X-ray System, Samsung Electronics Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/gc85a-gc85a (data as of 2026-11-15).",
  "source": {
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    "markdown_url": "https://devicerts.com/devices/gc85a-gc85a.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
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        "url": "https://ec.europa.eu/tools/eudamed"
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        "url": "https://accessgudid.nlm.nih.gov/"
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      }
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    "registry_records_last_synced": "2026-10-25",
    "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/gc85a-gc85a",
    "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": "GC85A Digital Diagnostic X-ray System",
    "registry_name": "GC85A",
    "url": "https://devicerts.com/devices/gc85a-gc85a",
    "manufacturer": {
      "name": "Samsung Electronics Co., Ltd",
      "url": "https://devicerts.com/manufacturers/samsung-electronics-coltd-kr-mf-000020682",
      "country": "South Korea",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union and United States"
    },
    "classification": [
      {
        "class": "Class IIb",
        "system": "EU MDR"
      },
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "08806088565231",
            "registries": [
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              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "Basic UDI-DI",
        "values": [
          {
            "value": "8806090DGRGC001VD",
            "registries": [
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        ]
      },
      {
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        "values": [
          {
            "value": "K150165",
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          },
          {
            "value": "K160997",
            "registries": [
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            ]
          },
          {
            "value": "K172229",
            "registries": [
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          },
          {
            "value": "K181629",
            "registries": [
              "FDA GUDID (AccessGUDID)"
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          },
          {
            "value": "K182183",
            "registries": [
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        ]
      }
    ],
    "product_codes": [
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      "MQB"
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    "emdn": [
      {
        "code": "Z11031101",
        "term": "MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY"
      }
    ],
    "gmdn": [
      {
        "code": "37645",
        "term": "Stationary basic diagnostic x-ray system, digital"
      }
    ],
    "description": {
      "text": "The GC85A is a Digital Diagnostic X-ray System, classified under nomenclature code Z11031101. This device generates radiographic images for diagnostic purposes, enabling visualisation of internal body structures such as bones, organs, and tissues through controlled X-ray exposure. It operates as a Class IIb medical device, adhering to stringent safety and performance standards for imaging applications.\n\nThe GC85A is a non-sterile, non-reusable system designed for use in clinical settings such as hospitals, diagnostic centres, and radiology departments. Supplied as a single-use component-free unit, it requires proper calibration and maintenance as specified by the manufacturer. The device is authorised under FDA 510K and MDR compliance, ensuring adherence to regulatory requirements for diagnostic imaging equipment. Storage and operational conditions must follow manufacturer guidelines to preserve functionality and image quality.",
      "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."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDR",
      "number": "8806090DGRGC001VD",
      "number_label": "Basic UDI-DI",
      "device_udi_di": "08806088565231",
      "date": "2026-04-21",
      "date_kind": "registered",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K182183",
      "number_label": null,
      "device_udi_di": null,
      "date": "2018-12-07",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    },
    {
      "registry": "510(k)",
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      "type": "FDA 510(k)",
      "number": "K181629",
      "number_label": null,
      "device_udi_di": null,
      "date": "2018-07-20",
      "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": "K172229",
      "number_label": null,
      "device_udi_di": null,
      "date": "2017-11-22",
      "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": "08806088565231",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2016-09-24",
      "date_kind": "listed",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Listed",
      "status_note": "GUDID: in commercial distribution",
      "derived_from_gudid": false
    },
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K160997",
      "number_label": null,
      "device_udi_di": null,
      "date": "2016-07-06",
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      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K150165",
      "number_label": null,
      "device_udi_di": null,
      "date": "2015-04-02",
      "date_kind": "issued",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
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            }
          ]
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}