{
  "code": "MQB",
  "deviceName": "Solid State X-Ray Imager (Flat Panel/Digital Imager)",
  "deviceClass": "II",
  "regulationNumber": "892.1680",
  "panel": "Radiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 423,
    "last12Months": 3
  },
  "adverseEvents": {
    "total": 278,
    "last12Months": 55
  },
  "reviewDays": {
    "median": 56,
    "sampleSize": 423
  },
  "recalls": {
    "total": 195,
    "recent": [
      {
        "resNumber": "Z-2354-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America Llc",
        "reason": "System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.",
        "initiated": "2026-05-01"
      },
      {
        "resNumber": "Z-0465-2026",
        "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-2042-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America Llc",
        "reason": "There is a software login in issue that may prevent the user from logging in.",
        "initiated": "2023-05-19"
      },
      {
        "resNumber": "Z-0239-2022",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips Healthcare Inc.",
        "firmAsPublished": "Philips Healthcare",
        "reason": "The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards.\nThis includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification\nstatement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.",
        "initiated": "2021-09-22"
      },
      {
        "resNumber": "Z-1992-2021",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "LIEBEL-FLARSHEIM COMPANY LLC",
        "firmAsPublished": "LIEBEL-FLARSHEIM COMPANY LLC",
        "reason": "Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than  35 percent. The dosage displayed on the generator console and table display (monitor) is higher than the actual delivered dose.",
        "initiated": "2021-03-11"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K260820",
      "deviceName": "VIVIX-S 4386W (FXRD-4386WA)",
      "applicant": "Vieworks Co., Ltd.",
      "company": "Vieworks Co., Ltd.",
      "decisionDate": "2026-06-18",
      "dateReceived": "2026-03-13"
    },
    {
      "kNumber": "K252996",
      "deviceName": "Universal 1417PI",
      "applicant": "Konica Minolta Healthcare Americas, Inc.",
      "company": "Konica Minolta Healthcare Americas, Inc.",
      "decisionDate": "2026-06-12",
      "dateReceived": "2025-09-18"
    },
    {
      "kNumber": "K252911",
      "deviceName": "Lux HD 2530 detector (Lux HD 2530)",
      "applicant": "Iray Imaging Technology (Haining) Limited",
      "company": "iRay Imaging Technology (Haining) Limited",
      "decisionDate": "2025-10-09",
      "dateReceived": "2025-09-12"
    },
    {
      "kNumber": "K250211",
      "deviceName": "Yushan X-Ray Flat Panel Detector",
      "applicant": "Innocare Optoelectronics Corp.",
      "company": "Innocare Optoelectronics Corp.",
      "decisionDate": "2025-07-22",
      "dateReceived": "2025-01-24"
    },
    {
      "kNumber": "K250665",
      "deviceName": "SKR 3000",
      "applicant": "Konica Minolta, Inc.",
      "company": "Konica Minolta, Inc.",
      "decisionDate": "2025-06-17",
      "dateReceived": "2025-03-05"
    },
    {
      "kNumber": "K243734",
      "deviceName": "Wireless/ Wired X-Ray Flat Panel Detectors",
      "applicant": "Allengers Medical Systems Limited",
      "company": "Allengers Medical Systems Limited",
      "decisionDate": "2025-04-18",
      "dateReceived": "2024-12-04"
    },
    {
      "kNumber": "K242770",
      "deviceName": "EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG",
      "applicant": "DRTECH Corporation",
      "company": "DRTECH Corporation",
      "decisionDate": "2025-03-20",
      "dateReceived": "2024-09-13"
    },
    {
      "kNumber": "K243443",
      "deviceName": "EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP",
      "applicant": "DRTECH Corporation",
      "company": "DRTECH Corporation",
      "decisionDate": "2025-03-19",
      "dateReceived": "2024-11-06"
    },
    {
      "kNumber": "K243556",
      "deviceName": "Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)",
      "applicant": "Iray Imaging Technology (Haining) Limited",
      "company": "iRay Imaging Technology (Haining) Limited",
      "decisionDate": "2025-03-18",
      "dateReceived": "2024-11-18"
    },
    {
      "kNumber": "K244010",
      "deviceName": "ExamVue Apex",
      "applicant": "Jpi Healthcare Co, Ltd.",
      "company": "Jpi Healthcare Co, Ltd.",
      "decisionDate": "2025-02-24",
      "dateReceived": "2024-12-26"
    }
  ],
  "topApplicants": [
    {
      "name": "Rayence Co., Ltd.",
      "count": 28
    },
    {
      "name": "Canon, Inc.",
      "count": 27
    },
    {
      "name": "Iray Technology Taicang , Ltd.",
      "count": 17
    },
    {
      "name": "DRTECH Corporation",
      "count": 14
    },
    {
      "name": "Vieworks Co., Ltd.",
      "count": 14
    }
  ],
  "topCompanies": [
    {
      "name": "Rayence Co., Ltd.",
      "count": 28,
      "spellings": 1
    },
    {
      "name": "Canon Inc.",
      "count": 27,
      "spellings": 1
    },
    {
      "name": "DRTECH Corporation",
      "count": 18,
      "spellings": 2
    },
    {
      "name": "Iray Technology Taicang , Ltd.",
      "count": 17,
      "spellings": 1
    },
    {
      "name": "Carestream Health, Inc.",
      "count": 15,
      "spellings": 2
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 9,
        "expectedLow": 0.9732551163806147,
        "expectedHigh": 16.41633162854961,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 9,
        "expectedLow": 1.7899308704399408,
        "expectedHigh": 13.587286448504068,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 17,
        "expectedLow": 2.744952432832842,
        "expectedHigh": 15.399814143312044,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 13,
        "expectedLow": 3.522957921661674,
        "expectedHigh": 20.090682395147788,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 11,
        "expectedLow": 4.0342929330450925,
        "expectedHigh": 18.799500590759575,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 9,
        "expectedLow": 4.712320978088669,
        "expectedHigh": 18.687096486573576,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 16,
        "expectedLow": 8.004043694123634,
        "expectedHigh": 26.623151613795688,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 7,
        "expectedLow": 5.923938227160599,
        "expectedHigh": 19.597779097926338,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 7,
        "expectedLow": 3.702833588673823,
        "expectedHigh": 19.408881608012297,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 9,
        "expectedLow": 1.75893399803869,
        "expectedHigh": 18.436998138602487,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 14,
        "expectedLow": 1.4643487369479131,
        "expectedHigh": 16.326578870908524,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 16,
        "expectedLow": 3.2563706390018026,
        "expectedHigh": 19.657612728959343,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 1,
        "expectedLow": 5.405445030668882,
        "expectedHigh": 24.249750648581518,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 19.468087795686753,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 1,
        "expectedLow": 0,
        "expectedHigh": 20.651887247146316,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)) has two findings, most consequential first. 2 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2354-2026, Z-0465-2026). The code is crowded, scoring 64 of 100 — 118 companies hold a clearance here and 3 arrived in the last 12 months (MQB:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "2 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2354-2026",
          "Z-0465-2026"
        ],
        "severity": 75
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 64 of 100 — 118 companies hold a clearance here and 3 arrived in the last 12 months",
        "recordIds": [
          "MQB: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%3AMQB"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMQB"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMQB"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AMQB"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AMQB"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AMQB"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AMQB"
    }
  ],
  "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": "2026-08-11T13:51:45.745Z"
}