{
  "format": "devicerts.device.v1",
  "cite_as": "Promo Mobile X-Ray System, DRGEM Corporation. deviCERTS medical device catalogue. https://devicerts.com/devices/promo-izl (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/promo-izl",
    "json_url": "https://devicerts.com/devices/promo-izl.json",
    "markdown_url": "https://devicerts.com/devices/promo-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_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/promo-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": "Promo Mobile X-Ray System",
    "registry_name": "PROMO",
    "url": "https://devicerts.com/devices/promo-izl",
    "manufacturer": {
      "name": "DRGEM Corporation",
      "url": "https://devicerts.com/manufacturers/drgem-corporation",
      "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": "08800011150105",
            "registries": [
              "EUDAMED",
              "FDA GUDID (AccessGUDID)"
            ]
          },
          {
            "value": "08800011150112",
            "registries": [
              "EUDAMED",
              "FDA GUDID (AccessGUDID)"
            ]
          },
          {
            "value": "08800011151003",
            "registries": [
              "EUDAMED"
            ]
          },
          {
            "value": "08800011151010",
            "registries": [
              "EUDAMED"
            ]
          }
        ]
      },
      {
        "label": "Basic UDI-DI",
        "values": [
          {
            "value": "88000111DMP5000ZP",
            "registries": [
              "EUDAMED"
            ]
          }
        ]
      },
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K251443",
            "registries": [
              "FDA 510(k)",
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "IZL",
      "MQB"
    ],
    "emdn": [
      {
        "code": "Z11031101",
        "term": "MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY"
      }
    ],
    "gmdn": [
      {
        "code": "37647",
        "term": "Mobile basic diagnostic x-ray system, digital"
      }
    ],
    "description": {
      "text": "The Promo Mobile X-Ray System is a portable radiographic imaging device designed for mobile radiography applications. It generates high-quality X-ray images for diagnostic purposes, supporting flexible positioning and stable mobility to enhance workflow efficiency in various clinical settings.\n\nThis system is intended for single-use or reusable applications, depending on the configuration, and is regulated under FDA 510(k) clearance and MDR compliance. It operates within Class II medical device classification and is intended for use in radiology departments, emergency settings, and other mobile imaging scenarios. The device is supplied with multiple FEI numbers and registration identifiers, ensuring traceability and adherence to regulatory standards.",
      "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": "88000111DMP5000ZP",
      "number_label": "Basic UDI-DI",
      "device_udi_di": null,
      "date": "2026-05-20",
      "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": "GUDID listing",
      "number": "08800011150105",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2025-08-26",
      "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": "K251443",
      "number_label": null,
      "device_udi_di": null,
      "date": "2025-08-22",
      "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": "Identity",
      "fields": [
        {
          "label": "Trade name",
          "values": [
            {
              "value": "PROMO",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "DRGEM",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Generic name",
          "values": [
            {
              "value": "Mobile basic diagnostic x-ray system, digital",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Model / reference",
          "values": [
            {
              "value": "PROMO",
              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "Primary DI / UDI-DI",
          "values": [
            {
              "value": "08800011150105",
              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
              ]
            },
            {
              "value": "08800011150112",
              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
              ]
            },
            {
              "value": "08800011151003",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "08800011151010",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Basic UDI-DI",
          "values": [
            {
              "value": "88000111DMP5000ZP",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K251443",
              "registries": [
                "FDA 510(k)",
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "IZL",
              "registries": [
                "FDA 510(k)",
                "FDA GUDID (AccessGUDID)"
              ]
            },
            {
              "value": "MQB",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "EMDN code",
          "values": [
            {
              "value": "Z11031101",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "GMDN term",
          "values": [
            {
              "value": "Mobile basic diagnostic x-ray system, digital",
              "code": "37647",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class IIb",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)",
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 892.1720",
              "registries": [
                "FDA 510(k)",
                "FDA GUDID (AccessGUDID)"
              ]
            },
            {
              "value": "892.1680",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "EU registration type",
          "values": [
            {
              "value": "Standard device",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "EU market of registration",
          "values": [
            {
              "value": "Türkiye",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "Poland",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Radiology",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "GUDID distribution status",
          "values": [
            {
              "value": "In Commercial Distribution",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Properties",
      "fields": [
        {
          "label": "Prescription use",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Serial number",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Manufacturing date",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Supplied sterile",
          "values": [
            {
              "value": "No",
              "registries": [
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                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "Sterilise before use",
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            {
              "value": "No",
              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Single use",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Implantable",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "Reusable",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains latex",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Reprocessed single-use device",
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            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)",
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              "value": "No",
              "registries": [
                "EUDAMED"
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            }
          ]
        },
        {
          "label": "Incorporates a substance derived from human blood or plasma",
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              "registries": [
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            }
          ]
        },
        {
          "label": "Contains human tissues or cells",
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            {
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              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains animal tissues or cells",
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              "registries": [
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            }
          ]
        },
        {
          "label": "Contains endocrine-disrupting substances",
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            {
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              "registries": [
                "EUDAMED"
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            }
          ]
        },
        {
          "label": "Administering medicine",
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            {
              "value": "No",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "Measuring function",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Incorporates a medicinal substance",
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            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Over-the-counter",
          "values": [
            {
              "value": "No",
              "registries": [
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            }
          ]
        },
        {
          "label": "Convenience kit",
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              "registries": [
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              ]
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          ]
        },
        {
          "label": "Combination product",
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            }
          ]
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        {
          "label": "HCT/P",
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              "registries": [
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            }
          ]
        },
        {
          "label": "Premarket exempt",
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            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Lot / batch number",
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              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "Expiration date",
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              "registries": [
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              ]
            }
          ]
        }
      ]
    }
  ]
}