{
  "code": "KPR",
  "deviceName": "System, X-Ray, Stationary",
  "deviceClass": "II",
  "regulationNumber": "892.1680",
  "panel": "Radiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 356,
    "last12Months": 6
  },
  "adverseEvents": {
    "total": 120,
    "last12Months": 32
  },
  "reviewDays": {
    "median": 57,
    "sampleSize": 356
  },
  "recalls": {
    "total": 168,
    "recent": [
      {
        "resNumber": "Z-1299-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "FUJIFILM Healthcare Americas Corporation",
        "firmAsPublished": "FUJIFILM Healthcare Americas Corporation",
        "reason": "It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.",
        "initiated": "2026-01-09"
      },
      {
        "resNumber": "Z-0464-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips Medical Systems DMC GmbH",
        "firmAsPublished": "Philips Medical Systems DMC GmbH",
        "reason": "Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024\nthrough June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required\nfor manual movement) due to potential manufacturing issues.",
        "initiated": "2025-10-01"
      },
      {
        "resNumber": "Z-0466-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips Medical Systems DMC GmbH",
        "firmAsPublished": "Philips Medical Systems DMC GmbH",
        "reason": "Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024\nthrough June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required\nfor manual movement) due to potential manufacturing issues.",
        "initiated": "2025-10-01"
      },
      {
        "resNumber": "Z-0044-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "FUJIFILM Healthcare Americas Corporation",
        "firmAsPublished": "FUJIFILM Healthcare Americas Corporation",
        "reason": "It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.",
        "initiated": "2025-09-15"
      },
      {
        "resNumber": "Z-1553-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America Llc",
        "reason": "Potential for collimator to fall as a result of incorrect installation.",
        "initiated": "2025-03-10"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K260482",
      "deviceName": "DRE Duo",
      "applicant": "Jpi Healthcare Co, Ltd.",
      "company": "Jpi Healthcare Co, Ltd.",
      "decisionDate": "2026-06-15",
      "dateReceived": "2026-02-13"
    },
    {
      "kNumber": "K253446",
      "deviceName": "AeroDR TX c02",
      "applicant": "Dk Medical Systems Co., Ltd.",
      "company": "Dk Medical Systems Co., Ltd.",
      "decisionDate": "2026-04-10",
      "dateReceived": "2025-10-02"
    },
    {
      "kNumber": "K250954",
      "deviceName": "DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector",
      "applicant": "Carestream Health",
      "company": "Carestream Health, Inc.",
      "decisionDate": "2026-01-20",
      "dateReceived": "2025-03-28"
    },
    {
      "kNumber": "K252000",
      "deviceName": "uDR Arria & uDR Aris",
      "applicant": "Shanghai United Imaging Healthcare Co., Ltd.",
      "company": "Shanghai United Imaging Healthcare Co., Ltd.",
      "decisionDate": "2025-11-26",
      "dateReceived": "2025-06-27"
    },
    {
      "kNumber": "K251167",
      "deviceName": "uDR Aurora CX",
      "applicant": "Shanghai United Imaging Healthcare Co., Ltd.",
      "company": "Shanghai United Imaging Healthcare Co., Ltd.",
      "decisionDate": "2025-09-19",
      "dateReceived": "2025-04-15"
    },
    {
      "kNumber": "K250788",
      "deviceName": "Definium Tempo Select",
      "applicant": "Ge Hualun Medical Systems Co. , Ltd.",
      "company": "Ge Hualun Medical Systems Co. , Ltd.",
      "decisionDate": "2025-08-28",
      "dateReceived": "2025-03-14"
    },
    {
      "kNumber": "K250790",
      "deviceName": "INNOVISION-DXII",
      "applicant": "Dk Medical Systems Co., Ltd.",
      "company": "Dk Medical Systems Co., Ltd.",
      "decisionDate": "2025-08-01",
      "dateReceived": "2025-03-14"
    },
    {
      "kNumber": "K250738",
      "deviceName": "YSIO X.pree",
      "applicant": "Siemens Medical Solutions",
      "company": "Siemens Medical Solutions",
      "decisionDate": "2025-07-31",
      "dateReceived": "2025-03-11"
    },
    {
      "kNumber": "K242019",
      "deviceName": "GXR-Series Diagnostic X-Ray System",
      "applicant": "DRGEM Corporation",
      "company": "DRGEM Corporation",
      "decisionDate": "2025-01-07",
      "dateReceived": "2024-07-10"
    },
    {
      "kNumber": "K242499",
      "deviceName": "Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))",
      "applicant": "Shenzhen Sontu Medical Imaging Equipment Co., Ltd.",
      "company": "Shenzhen Sontu Medical Imaging Equipment Co., Ltd.",
      "decisionDate": "2025-01-06",
      "dateReceived": "2024-08-22"
    }
  ],
  "topApplicants": [
    {
      "name": "Samsung Electronics Co., Ltd.",
      "count": 20
    },
    {
      "name": "Siemens Medical Solutions USA, Inc.",
      "count": 13
    },
    {
      "name": "Imaging Dynamics Company , Ltd.",
      "count": 11
    },
    {
      "name": "Carestream Health, Inc.",
      "count": 10
    },
    {
      "name": "Octostop, Inc.",
      "count": 8
    }
  ],
  "topCompanies": [
    {
      "name": "Samsung Electronics Co., Ltd.",
      "count": 20,
      "spellings": 1
    },
    {
      "name": "Siemens Medical Solutions USA, Inc.",
      "count": 13,
      "spellings": 1
    },
    {
      "name": "Carestream Health, Inc.",
      "count": 11,
      "spellings": 2
    },
    {
      "name": "Imaging Dynamics Company Limited",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "GE Medical Systems, LLC",
      "count": 9,
      "spellings": 3
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-05-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 4,
        "expectedLow": 0,
        "expectedHigh": 8.537423044085015,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 7.288380888500504,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 9,
        "expectedLow": 0,
        "expectedHigh": 7.7756435458285456,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 3,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "KPR (System, X-Ray, Stationary) has three findings, most consequential first. 4 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1299-2026, Z-0464-2026, Z-0466-2026, Z-0044-2026). Adverse events reported in 2026-03 ran high — 9 reports against an expected 0 to 8 (KPR:MAUDE:2026-03). The code is crowded, scoring 71 of 100 — 155 companies hold a clearance here and 6 arrived in the last 12 months (KPR:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "4 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1299-2026",
          "Z-0464-2026",
          "Z-0466-2026",
          "Z-0044-2026"
        ],
        "severity": 75
      },
      {
        "kind": "spike",
        "detail": "adverse events reported in 2026-03 ran high — 9 reports against an expected 0 to 8",
        "recordIds": [
          "KPR:MAUDE:2026-03"
        ],
        "severity": 63
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 71 of 100 — 155 companies hold a clearance here and 6 arrived in the last 12 months",
        "recordIds": [
          "KPR:crowding"
        ],
        "severity": 20
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AKPR"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKPR"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKPR"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AKPR"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AKPR"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AKPR"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AKPR"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.735Z"
}