{
  "format": "devicerts.device.v1",
  "cite_as": "DuraDiagnost X-Ray System, Philips Healthcare (Suzhou) Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/duradiagnost-kpr (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/duradiagnost-kpr",
    "json_url": "https://devicerts.com/devices/duradiagnost-kpr.json",
    "markdown_url": "https://devicerts.com/devices/duradiagnost-kpr.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": "2026-11-14",
    "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/duradiagnost-kpr",
    "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": "DuraDiagnost X-Ray System",
    "registry_name": "DURADIAGNOST",
    "url": "https://devicerts.com/devices/duradiagnost-kpr",
    "manufacturer": {
      "name": "Philips Healthcare (Suzhou) Co., Ltd.",
      "url": "https://devicerts.com/manufacturers/fda-fei-3009529630",
      "country": "China",
      "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": "Catalogue number",
        "values": [
          {
            "value": "712203",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "00884838095205",
            "registries": [
              "EUDAMED",
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "Basic UDI-DI",
        "values": [
          {
            "value": "0884838BM287TA",
            "registries": [
              "EUDAMED"
            ]
          }
        ]
      },
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K141381",
            "registries": [
              "FDA 510(k)"
            ]
          },
          {
            "value": "K201640",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "KPR"
    ],
    "emdn": [
      {
        "code": "Z11031101",
        "term": "MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY"
      }
    ],
    "gmdn": [
      {
        "code": "37645",
        "term": "Stationary basic diagnostic x-ray system, digital"
      }
    ],
    "description": {
      "text": "The DuraDiagnost is a stationary X-ray imaging system designed for radiography. It incorporates key components such as an integrated tube column, a patient table with a floating tabletop, and a high-voltage generator to produce high-quality radiographic images. This system supports dual-focus rotation anode technology for enhanced imaging performance across various clinical applications.\n\nThe DuraDiagnost is intended for use in radiology departments and clinical settings requiring stationary X-ray imaging. It is supplied as a reusable, non-sterile device with multiple model and reference codes (e.g., 3003768277, 3009715136). The system complies with FDA 510(k) clearance and MDR authorizations, adhering to regulatory standards for Class II medical devices under product code KPR. Storage and handling follow manufacturer guidelines to ensure optimal performance and safety.",
      "ai_generated": true,
      "generated_on": "2026-09-20",
      "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": "0884838BM287TA",
      "number_label": "Basic UDI-DI",
      "device_udi_di": "00884838095205",
      "date": "2024-11-27",
      "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": "00884838095205",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2020-09-04",
      "date_kind": "listed",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Listed",
      "status_note": "GUDID: not in commercial distribution",
      "derived_from_gudid": false
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K201640",
      "number_label": null,
      "device_udi_di": null,
      "date": "2020-07-09",
      "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": "K141381",
      "number_label": null,
      "device_udi_di": null,
      "date": "2014-06-12",
      "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": [
    {
      "number": "Z-1553-2025",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2025-03-10",
      "reason": "Potential for collimator to fall as a result of incorrect installation.",
      "applies": "this device",
      "via": "K141381"
    },
    {
      "number": "Z-1554-2025",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2025-03-10",
      "reason": "Potential for collimator to fall as a result of incorrect installation.",
      "applies": "this device",
      "via": "K141381"
    },
    {
      "number": "Z-2322-2017",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-05-31",
      "reason": "Tube arm assembly could fall down due to cracked welding joints",
      "applies": "this device",
      "via": "K141381"
    },
    {
      "number": "Z-1696-2016",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2015-11-10",
      "reason": "The detector may signal that it is ready for acquisition  when it actually is not, resulting in failure to properly acquire the X-ray image.",
      "applies": "this device",
      "via": "K141381"
    },
    {
      "number": "Z-2682-2016",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2015-09-17",
      "reason": "Buttons or keys on the monitor allow the user to turn the volume setting down to 0\", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].",
      "applies": "this device",
      "via": "K141381"
    },
    {
      "number": "Z-1555-2015",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2015-02-09",
      "reason": "The system is designed to emit a beep upon termination of an exposure.  However, if the system has been powered on for over 12 hours, the system will no longer emit this signal.  This is a failure to comply with 21CFR 1020.31(j).",
      "applies": "this device",
      "via": "K141381"
    },
    {
      "number": "Z-1251-2015",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2015-01-23",
      "reason": "Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installation of table may cause it to float.",
      "applies": "this device",
      "via": "K141381"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Generic name",
          "values": [
            {
              "value": "Stationary basic diagnostic x-ray system, digital",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Model / Ref / Catalog",
          "values": [
            {
              "value": "712203",
              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
              ]
            },
            {
              "value": "DuraDiagnost",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "Primary DI / UDI-DI",
          "values": [
            {
              "value": "00884838095205",
              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Basic UDI-DI",
          "values": [
            {
              "value": "0884838BM287TA",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Direct marketing DI",
          "values": [
            {
              "value": "00884838095205",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K141381",
              "registries": [
                "FDA 510(k)"
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            },
            {
              "value": "K201640",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "KPR",
              "registries": [
                "FDA 510(k)",
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "EMDN code",
          "values": [
            {
              "value": "Z11031101",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "GMDN term",
          "values": [
            {
              "value": "Stationary basic diagnostic x-ray system, digital",
              "code": "37645",
              "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 892.1680",
              "registries": [
                "FDA 510(k)",
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "EU registration type",
          "values": [
            {
              "value": "Standard device",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "EU market of registration",
          "values": [
            {
              "value": "Germany",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Radiology",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
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            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "GUDID distribution status",
          "values": [
            {
              "value": "Not in Commercial Distribution",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Properties",
      "fields": [
        {
          "label": "Measuring function",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Prescription use",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Serial number",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Supplied sterile",
          "values": [
            {
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              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Sterilise before use",
          "values": [
            {
              "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)"
              ]
            }
          ]
        },
        {
          "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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              "registries": [
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            }
          ]
        },
        {
          "label": "Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)",
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              "registries": [
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            }
          ]
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        {
          "label": "Incorporates a substance derived from human blood or plasma",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains human tissues or cells",
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              "registries": [
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            }
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        {
          "label": "Contains animal tissues or cells",
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              "value": "No",
              "registries": [
                "EUDAMED"
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            }
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        },
        {
          "label": "Contains endocrine-disrupting substances",
          "values": [
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              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Administering medicine",
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            {
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              "registries": [
                "EUDAMED"
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            }
          ]
        },
        {
          "label": "Incorporates a medicinal substance",
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              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Over-the-counter",
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              "registries": [
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            }
          ]
        },
        {
          "label": "Convenience kit",
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              "value": "No",
              "registries": [
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            }
          ]
        },
        {
          "label": "Combination product",
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              "registries": [
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              "registries": [
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            }
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        {
          "label": "Premarket exempt",
          "values": [
            {
              "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": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "Manufacturing date",
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              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    }
  ]
}