{
  "format": "devicerts.device.v1",
  "cite_as": "GM85, Samsung Electronics Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/gm85-izl (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/gm85-izl",
    "json_url": "https://devicerts.com/devices/gm85-izl.json",
    "markdown_url": "https://devicerts.com/devices/gm85-izl.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "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/gm85-izl",
    "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": "GM85",
    "registry_name": "GM85",
    "url": "https://devicerts.com/devices/gm85-izl",
    "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": "08806088582412",
            "registries": [
              "EUDAMED",
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "Basic UDI-DI",
        "values": [
          {
            "value": "8806090DGRGM001XK",
            "registries": [
              "EUDAMED"
            ]
          }
        ]
      },
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K220175",
            "registries": [
              "FDA 510(k)",
              "FDA GUDID (AccessGUDID)"
            ]
          },
          {
            "value": "K162278",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          },
          {
            "value": "K171119",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          },
          {
            "value": "K180543",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          },
          {
            "value": "K181626",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          },
          {
            "value": "K182183",
            "registries": [
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            ]
          },
          {
            "value": "K222353",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "IZL",
      "MQB",
      "KPR"
    ],
    "emdn": [
      {
        "code": "Z11031101",
        "term": "MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY"
      }
    ],
    "gmdn": [
      {
        "code": "37647",
        "term": "Mobile basic diagnostic x-ray system, digital"
      }
    ],
    "description": {
      "text": "The GM85 is a Mobile X-Ray System (OpenFDA classification: IZL) designed for portable radiographic imaging. It generates X-ray images by transmitting ionizing radiation through a patient’s body, capturing the resulting signals via detectors and converting them into digital data for diagnostic evaluation. The system is configured for versatile radiographic applications, including general radiography and specialized imaging in mobile settings.\n\nThe GM85 is supplied as a reusable, non-sterile device intended for use in clinical radiology departments, emergency settings, or mobile imaging units. It features optional configurations, such as a collapsible column type with manual collimation, multiple detector options, and wired/wireless exposure switches. The system operates under FDA 510(k) clearance (K220175, K222353) and EU MDR compliance, with no MRI safety restrictions. Storage and handling follow standard radiographic equipment protocols.",
      "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": "8806090DGRGM001XK",
      "number_label": "Basic UDI-DI",
      "device_udi_di": "08806088582412",
      "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": "K222353",
      "number_label": null,
      "device_udi_di": null,
      "date": "2022-09-29",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    },
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K220175",
      "number_label": null,
      "device_udi_di": null,
      "date": "2022-04-21",
      "date_kind": "decision",
      "decision_code": "SESE",
      "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": "GUDID",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K181626",
      "number_label": null,
      "device_udi_di": null,
      "date": "2018-07-20",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K180543",
      "number_label": null,
      "device_udi_di": null,
      "date": "2018-05-24",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K171119",
      "number_label": null,
      "device_udi_di": null,
      "date": "2017-05-12",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "08806088582412",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2016-11-26",
      "date_kind": "listed",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Listed",
      "status_note": "GUDID: in commercial distribution",
      "derived_from_gudid": false
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K162278",
      "number_label": null,
      "device_udi_di": null,
      "date": "2016-11-15",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-0480-2026",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2025-10-07",
      "reason": "The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.",
      "applies": "this device",
      "via": "K222353"
    },
    {
      "number": "Z-1056-2024",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2023-12-28",
      "reason": "Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.",
      "applies": "this device",
      "via": "K222353"
    },
    {
      "number": "Z-1414-2023",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2023-03-08",
      "reason": "Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm",
      "applies": "this device",
      "via": "K222353"
    },
    {
      "number": "Z-1691-2019",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-05-06",
      "reason": "Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks.",
      "applies": "this device",
      "via": "K171119"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Generic name",
          "values": [
            {
              "value": "Mobile basic diagnostic x-ray system, digital",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Device name",
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            {
              "value": "Digital Diagnostic Mobile X-ray System",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Model / reference",
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            {
              "value": "GM85",
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            }
          ]
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      ]
    },
    {
      "group": "Identifiers",
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                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "Basic UDI-DI",
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            {
              "value": "8806090DGRGM001XK",
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            }
          ]
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          ]
        },
        {
          "label": "FDA product code",
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            {
              "value": "IZL",
              "registries": [
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                "FDA GUDID (AccessGUDID)"
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            },
            {
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          ]
        },
        {
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              "value": "Z11031101",
              "registries": [
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            }
          ]
        },
        {
          "label": "GMDN term",
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            {
              "value": "Mobile basic diagnostic x-ray system, digital",
              "code": "37647",
              "registries": [
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            }
          ]
        }
      ]
    },
    {
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            {
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              "registries": [
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              "value": "Class II",
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          ]
        },
        {
          "label": "Regulation",
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            {
              "value": "21 CFR Part 892.1720",
              "registries": [
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                "FDA GUDID (AccessGUDID)"
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            },
            {
              "value": "892.1680",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "System or procedure pack",
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            }
          ]
        },
        {
          "label": "EU registration type",
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              "value": "Standard device",
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            }
          ]
        },
        {
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          ]
        },
        {
          "label": "Advisory committee",
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          ]
        },
        {
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          ]
        },
        {
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        {
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            }
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        {
          "label": "Implantable",
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        {
          "label": "Contains latex",
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                "FDA GUDID (AccessGUDID)"
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          ]
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        {
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              "registries": [
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        {
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        {
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        {
          "label": "Measuring function",
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            }
          ]
        },
        {
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            }
          ]
        },
        {
          "label": "Over-the-counter",
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              "registries": [
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          ]
        },
        {
          "label": "Convenience kit",
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        {
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        {
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            }
          ]
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        {
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            }
          ]
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        {
          "label": "Lot / batch number",
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            }
          ]
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        {
          "label": "Expiration date",
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            }
          ]
        },
        {
          "label": "Manufacturing date",
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              "registries": [
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            }
          ]
        }
      ]
    }
  ]
}