{
  "code": "IZL",
  "deviceName": "System, X-Ray, Mobile",
  "deviceClass": "II",
  "regulationNumber": "892.1720",
  "panel": "Radiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 236,
    "last12Months": 8
  },
  "adverseEvents": {
    "total": 139,
    "last12Months": 17
  },
  "reviewDays": {
    "median": 58,
    "sampleSize": 236
  },
  "recalls": {
    "total": 170,
    "recent": [
      {
        "resNumber": "Z-2726-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GE Medical Systems, LLC",
        "firmAsPublished": "GE Medical Systems, LLC",
        "reason": "GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.",
        "initiated": "2026-06-05"
      },
      {
        "resNumber": "Z-2727-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GE Medical Systems, LLC",
        "firmAsPublished": "GE Medical Systems, LLC",
        "reason": "GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.",
        "initiated": "2026-06-05"
      },
      {
        "resNumber": "Z-2728-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GE Medical Systems, LLC",
        "firmAsPublished": "GE Medical Systems, LLC",
        "reason": "GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.",
        "initiated": "2026-06-05"
      },
      {
        "resNumber": "Z-1918-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Micro-X Ltd.",
        "firmAsPublished": "Micro-X Ltd.",
        "reason": "X-Ray generator  may malfunction resulting in the X-Ray being inoperable.",
        "initiated": "2026-03-27"
      },
      {
        "resNumber": "Z-0480-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "NeuroLogica Corporation",
        "firmAsPublished": "NeuroLogica Corporation",
        "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.",
        "initiated": "2025-10-07"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253058",
      "deviceName": "Portable DR Imaging System",
      "applicant": "Shantou Institute of Ultrasonic Instruments Co., Ltd.",
      "company": "Shantou Institute of Ultrasonic Instruments Co., Ltd.",
      "decisionDate": "2026-06-18",
      "dateReceived": "2025-09-22"
    },
    {
      "kNumber": "K260085",
      "deviceName": "RAYMO Mobile X-ray System (Model: RAYMO)",
      "applicant": "DRGEM Corporation",
      "company": "DRGEM Corporation",
      "decisionDate": "2026-05-14",
      "dateReceived": "2026-01-12"
    },
    {
      "kNumber": "K253185",
      "deviceName": "Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System",
      "applicant": "Carestream Health",
      "company": "Carestream Health, Inc.",
      "decisionDate": "2026-03-11",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K253244",
      "deviceName": "AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)",
      "applicant": "Poskom Co., Ltd.",
      "company": "Poskom Co., Ltd.",
      "decisionDate": "2026-02-23",
      "dateReceived": "2025-09-29"
    },
    {
      "kNumber": "K250976",
      "deviceName": "Airbile-100",
      "applicant": "Poskom Co., Ltd.",
      "company": "Poskom Co., Ltd.",
      "decisionDate": "2025-12-19",
      "dateReceived": "2025-03-31"
    },
    {
      "kNumber": "K251710",
      "deviceName": "Mobile X-ray unit (!M1)",
      "applicant": "Solutions For Tomorrow AB",
      "company": "Solutions For Tomorrow AB",
      "decisionDate": "2025-10-24",
      "dateReceived": "2025-06-03"
    },
    {
      "kNumber": "K243864",
      "deviceName": "BONX805",
      "applicant": "Bontech Co., Ltd.",
      "company": "Bontech Co., Ltd.",
      "decisionDate": "2025-09-12",
      "dateReceived": "2024-12-17"
    },
    {
      "kNumber": "K251443",
      "deviceName": "PROMO",
      "applicant": "DRGEM Corporation",
      "company": "DRGEM Corporation",
      "decisionDate": "2025-08-22",
      "dateReceived": "2025-05-09"
    },
    {
      "kNumber": "K251223",
      "deviceName": "HnX-P1, HnX-PB",
      "applicant": "H&abyz Co., Ltd.",
      "company": "H&abyz Co., Ltd.",
      "decisionDate": "2025-08-04",
      "dateReceived": "2025-04-21"
    },
    {
      "kNumber": "K250597",
      "deviceName": "REMEX Xcam6",
      "applicant": "Remedi, Inc.",
      "company": "Remedi Co., Ltd.",
      "decisionDate": "2025-07-31",
      "dateReceived": "2025-02-28"
    }
  ],
  "topApplicants": [
    {
      "name": "Sedecal., Sa.",
      "count": 17
    },
    {
      "name": "Minxray, Inc.",
      "count": 15
    },
    {
      "name": "General X-Ray, Inc.",
      "count": 11
    },
    {
      "name": "Samsung Electronics Co., Ltd.",
      "count": 8
    },
    {
      "name": "DRGEM Corporation",
      "count": 6
    }
  ],
  "topCompanies": [
    {
      "name": "SEDECAL SA",
      "count": 17,
      "spellings": 1
    },
    {
      "name": "Minxray, Inc.",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "General X-Ray, Inc.",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "GE Medical Systems, LLC",
      "count": 8,
      "spellings": 2
    },
    {
      "name": "Samsung Electronics Co., Ltd.",
      "count": 8,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Shantou Institute of Ultrasonic Instruments Co., Ltd.",
      "since": "2026-06-18",
      "kNumber": "K253058"
    },
    {
      "name": "Bontech Co., Ltd.",
      "since": "2025-09-12",
      "kNumber": "K243864"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "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": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 3,
        "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": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 6.100827883220493,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 5.9180555555922485,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 1,
        "expectedLow": 0,
        "expectedHigh": 6.163273385485137,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 3,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "IZL (System, X-Ray, Mobile) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2726-2026, Z-2727-2026, Z-2728-2026, Z-1918-2026, Z-0480-2026). 2 first-time filers in the last 12 months, Shantou Institute of Ultrasonic Instruments Co., Ltd. and Bontech Co., Ltd (K253058, K243864). The code is crowded, scoring 81 of 100 — 117 companies hold a clearance here and 8 arrived in the last 12 months (IZL:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2726-2026",
          "Z-2727-2026",
          "Z-2728-2026",
          "Z-1918-2026",
          "Z-0480-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "2 first-time filers in the last 12 months, Shantou Institute of Ultrasonic Instruments Co., Ltd. and Bontech Co., Ltd.",
        "recordIds": [
          "K253058",
          "K243864"
        ],
        "severity": 42
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 81 of 100 — 117 companies hold a clearance here and 8 arrived in the last 12 months",
        "recordIds": [
          "IZL: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%3AIZL"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AIZL"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AIZL"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AIZL"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AIZL"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AIZL"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AIZL"
    }
  ],
  "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": "2026-08-11T13:51:45.715Z"
}