{
  "code": "JAA",
  "deviceName": "System, X-Ray, Fluoroscopic, Image-Intensified",
  "deviceClass": "II",
  "regulationNumber": "892.1650",
  "panel": "Radiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 300,
    "last12Months": 2
  },
  "adverseEvents": {
    "total": 97,
    "last12Months": 19
  },
  "reviewDays": {
    "median": 67,
    "sampleSize": 300
  },
  "recalls": {
    "total": 223,
    "recent": [
      {
        "resNumber": "Z-0597-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America",
        "reason": "Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm\nstand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.",
        "initiated": "2025-10-27"
      },
      {
        "resNumber": "Z-0461-2026",
        "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-0462-2026",
        "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-0463-2026",
        "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-1981-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Siemens Medical Solutions USA, Inc.",
        "firmAsPublished": "Siemens Medical Solutions USA, Inc",
        "reason": "A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.",
        "initiated": "2025-06-04"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253103",
      "deviceName": "Nexus DRF Digital X-ray Imaging System",
      "applicant": "Varex Imaging Corporation",
      "company": "Varex Imaging Corporation",
      "decisionDate": "2026-05-29",
      "dateReceived": "2025-09-24"
    },
    {
      "kNumber": "K251650",
      "deviceName": "Insight Enhanced™ DRF (EN-1002-01)",
      "applicant": "Imaging Engineering, LLC",
      "company": "Imaging Engineering, LLC",
      "decisionDate": "2025-09-16",
      "dateReceived": "2025-05-29"
    },
    {
      "kNumber": "K242488",
      "deviceName": "Soteria E-View",
      "applicant": "Omega Medical Imaging, LLC",
      "company": "Omega Medical Imaging, Inc.",
      "decisionDate": "2025-01-06",
      "dateReceived": "2024-08-21"
    },
    {
      "kNumber": "K242948",
      "deviceName": "Adora DRFi (04550010)",
      "applicant": "Nrt X-Ray A/S",
      "company": "NRT X-RAY A/S",
      "decisionDate": "2024-12-23",
      "dateReceived": "2024-09-25"
    },
    {
      "kNumber": "K233380",
      "deviceName": "TRIDENT Mobile Fluoroscopy System",
      "applicant": "Dornier Medtech America",
      "company": "Dornier Medtech America, Inc.",
      "decisionDate": "2024-06-26",
      "dateReceived": "2023-10-02"
    },
    {
      "kNumber": "K233945",
      "deviceName": "ProxiDiagnost N90 / Precision CRF (706110, 706400)",
      "applicant": "Philips Medical Systems Dmc GmbH",
      "company": "Philips Medical Systems DMC GmbH",
      "decisionDate": "2024-01-11",
      "dateReceived": "2023-12-14"
    },
    {
      "kNumber": "K232910",
      "deviceName": "CombiDiagnost R90",
      "applicant": "Philips Medical Systems Dmc GmbH",
      "company": "Philips Medical Systems DMC GmbH",
      "decisionDate": "2023-10-19",
      "dateReceived": "2023-09-19"
    },
    {
      "kNumber": "K232526",
      "deviceName": "XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5",
      "applicant": "Canon Medical Systems Corporation",
      "company": "Canon Medical Systems Corporation",
      "decisionDate": "2023-09-12",
      "dateReceived": "2023-08-21"
    },
    {
      "kNumber": "K220871",
      "deviceName": "Nautilus",
      "applicant": "Dornier Medtech America, Inc.",
      "company": "Dornier Medtech America, Inc.",
      "decisionDate": "2022-04-18",
      "dateReceived": "2022-03-25"
    },
    {
      "kNumber": "K212890",
      "deviceName": "Nyquist.IQ",
      "applicant": "Omega Medical Imaging, LLC",
      "company": "Omega Medical Imaging, Inc.",
      "decisionDate": "2021-12-13",
      "dateReceived": "2021-09-10"
    }
  ],
  "topApplicants": [
    {
      "name": "Toshiba America Medical Systems, In.C",
      "count": 13
    },
    {
      "name": "Fischer Imaging Corp.",
      "count": 10
    },
    {
      "name": "General Electric Co.",
      "count": 10
    },
    {
      "name": "Shimadzu Medical Systems",
      "count": 10
    },
    {
      "name": "Siemens Medical Solutions USA, Inc.",
      "count": 10
    }
  ],
  "topCompanies": [
    {
      "name": "Toshiba America Medical Systems, In.C",
      "count": 13,
      "spellings": 1
    },
    {
      "name": "Fischer Imaging Corporation",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "General Electric Company",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Shimadzu Medical Systems",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Siemens Medical Solutions USA, Inc.",
      "count": 10,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Varex Imaging Corporation",
      "since": "2026-05-29",
      "kNumber": "K253103"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-05-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 4,
        "expectedLow": 0.9273681539316199,
        "expectedHigh": 5.400944642985355,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 3,
        "expectedLow": 1.3891923577716887,
        "expectedHigh": 4.852054589587542,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 1,
        "expectedLow": 1.6458022560140761,
        "expectedHigh": 5.15600110034766,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 3,
        "expectedLow": 0.6210258063561187,
        "expectedHigh": 5.577206644422861,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 1,
        "expectedLow": 0.5419869777387372,
        "expectedHigh": 4.665522711923674,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 1,
        "expectedLow": 0,
        "expectedHigh": 4.62640394913273,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 6,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "JAA (System, X-Ray, Fluoroscopic, Image-Intensified) has three findings, most consequential first. 4 recalls opened in the last 12 months and not yet terminated (Class II) (Z-0597-2026, Z-0461-2026, Z-0462-2026, Z-0463-2026). 1 first-time filer in the last 12 months, Varex Imaging Corporation (K253103). The code is crowded, scoring 72 of 100 — 152 companies hold a clearance here and 2 arrived in the last 12 months (JAA:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "4 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-0597-2026",
          "Z-0461-2026",
          "Z-0462-2026",
          "Z-0463-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Varex Imaging Corporation",
        "recordIds": [
          "K253103"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 72 of 100 — 152 companies hold a clearance here and 2 arrived in the last 12 months",
        "recordIds": [
          "JAA: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%3AJAA"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJAA"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJAA"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJAA"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJAA"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJAA"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJAA"
    }
  ],
  "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"
}