{
  "code": "OWB",
  "deviceName": "Interventional Fluoroscopic X-Ray System",
  "deviceClass": "II",
  "regulationNumber": "892.1650",
  "panel": "Radiology",
  "definition": "Interventional fluoroscopy",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 321,
    "last12Months": 17
  },
  "adverseEvents": {
    "total": 28714,
    "last12Months": 8971
  },
  "reviewDays": {
    "median": 89,
    "sampleSize": 321
  },
  "recalls": {
    "total": 620,
    "recent": [
      {
        "resNumber": "Z-2891-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Philips Medical Systems Nederland B.V.",
        "firmAsPublished": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.",
        "reason": "Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.",
        "initiated": "2026-06-17"
      },
      {
        "resNumber": "Z-2892-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Philips Medical Systems Nederland B.V.",
        "firmAsPublished": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.",
        "reason": "Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.",
        "initiated": "2026-06-17"
      },
      {
        "resNumber": "Z-2893-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Philips Medical Systems Nederland B.V.",
        "firmAsPublished": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.",
        "reason": "Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.",
        "initiated": "2026-06-17"
      },
      {
        "resNumber": "Z-2857-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Oxos Medical, Inc.",
        "firmAsPublished": "Oxos Medical Inc",
        "reason": "Due to a defective circuit board that overheats",
        "initiated": "2026-06-11"
      },
      {
        "resNumber": "Z-2648-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Siemens Medical Solutions USA, Inc.",
        "firmAsPublished": "Siemens Medical Solutions USA, Inc",
        "reason": "Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.",
        "initiated": "2026-06-08"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253670",
      "deviceName": "SmartCT (R3.0 (L10))",
      "applicant": "Philips Medical Systems B.V.",
      "company": "Philips Medical Systems B.V.",
      "decisionDate": "2026-07-10",
      "dateReceived": "2025-11-21"
    },
    {
      "kNumber": "K252735",
      "deviceName": "C-beam",
      "applicant": "Pulmera, Inc.",
      "company": "Pulmera, Inc.",
      "decisionDate": "2026-05-22",
      "dateReceived": "2025-08-28"
    },
    {
      "kNumber": "K252503",
      "deviceName": "Intelligent NR",
      "applicant": "Canon, Inc.",
      "company": "Canon Inc.",
      "decisionDate": "2026-04-30",
      "dateReceived": "2025-08-08"
    },
    {
      "kNumber": "K254173",
      "deviceName": "ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno",
      "applicant": "Siemens Medical Solutions USA, Inc.",
      "company": "Siemens Medical Solutions USA, Inc.",
      "decisionDate": "2026-04-24",
      "dateReceived": "2025-12-23"
    },
    {
      "kNumber": "K253752",
      "deviceName": "ARTIS genio floor; ARTIS icono.explore floor",
      "applicant": "Siemens Medical Solutions USA, Inc.",
      "company": "Siemens Medical Solutions USA, Inc.",
      "decisionDate": "2026-04-23",
      "dateReceived": "2025-11-25"
    },
    {
      "kNumber": "K252229",
      "deviceName": "BELLIGER ACE",
      "applicant": "Genoray Co., Ltd.",
      "company": "Genoray Co., Ltd.",
      "decisionDate": "2026-04-02",
      "dateReceived": "2025-07-16"
    },
    {
      "kNumber": "K252099",
      "deviceName": "Trinias",
      "applicant": "Shimadzu Corporation",
      "company": "Shimadzu Corporation",
      "decisionDate": "2026-03-24",
      "dateReceived": "2025-07-03"
    },
    {
      "kNumber": "K253584",
      "deviceName": "Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)",
      "applicant": "Canon Medical Systems Corporation",
      "company": "Canon Medical Systems Corporation",
      "decisionDate": "2026-03-10",
      "dateReceived": "2025-11-17"
    },
    {
      "kNumber": "K252500",
      "deviceName": "CARA System",
      "applicant": "Cara Medical, Ltd.",
      "company": "Cara Medical, Ltd.",
      "decisionDate": "2026-02-20",
      "dateReceived": "2025-08-08"
    },
    {
      "kNumber": "K251992",
      "deviceName": "ArmSure Fluoroscopic Positioning System",
      "applicant": "Savfe Co. , Ltd.",
      "company": "Savfe Co. , Ltd.",
      "decisionDate": "2026-02-11",
      "dateReceived": "2025-06-27"
    }
  ],
  "topApplicants": [
    {
      "name": "Siemens Medical Solutions USA, Inc.",
      "count": 37
    },
    {
      "name": "Philips Medical Systems Nederland B.V.",
      "count": 28
    },
    {
      "name": "Ziehm Imaging GmbH",
      "count": 16
    },
    {
      "name": "Toshibamedical Systems Corporation",
      "count": 13
    },
    {
      "name": "Canon Medical Systems Corporation",
      "count": 12
    }
  ],
  "topCompanies": [
    {
      "name": "Siemens Medical Solutions USA, Inc.",
      "count": 37,
      "spellings": 1
    },
    {
      "name": "Philips Medical Systems Nederland B.V.",
      "count": 28,
      "spellings": 1
    },
    {
      "name": "Ziehm Imaging Inc",
      "count": 21,
      "spellings": 2
    },
    {
      "name": "Toshibamedical Systems Corporation",
      "count": 13,
      "spellings": 1
    },
    {
      "name": "Canon Medical Systems Corporation",
      "count": 12,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Pulmera, Inc.",
      "since": "2026-05-22",
      "kNumber": "K252735"
    },
    {
      "name": "Cara Medical, Ltd.",
      "since": "2026-02-20",
      "kNumber": "K252500"
    },
    {
      "name": "Savfe Co. , Ltd.",
      "since": "2026-02-11",
      "kNumber": "K251992"
    },
    {
      "name": "Skanray Technologies Pvt, Ltd.",
      "since": "2025-12-16",
      "kNumber": "K251893"
    },
    {
      "name": "Philips Medical Systems B.V.",
      "since": "2025-10-24",
      "kNumber": "K251827"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 617,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 452,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 943,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 545,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 820,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 533,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 428,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 518,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 656,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 524,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 862,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 645,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 562,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 627,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 534,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 654,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 698,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 698,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 726,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 729,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 683,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 674,
        "expectedLow": 456.80856277497077,
        "expectedHigh": 796.1487539506328,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 851,
        "expectedLow": 427.7030144358315,
        "expectedHigh": 696.7073985838533,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 559,
        "expectedLow": 508.08517272308325,
        "expectedHigh": 938.6931374372278,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 902,
        "expectedLow": 468.8915622278291,
        "expectedHigh": 922.2375275499788,
        "isSufficient": true
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      {
        "month": "2025-05-01",
        "observed": 836,
        "expectedLow": 462.03426458327516,
        "expectedHigh": 959.1980769716557,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 1072,
        "expectedLow": 496.2305848706252,
        "expectedHigh": 1054.4570287642082,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 1066,
        "expectedLow": 814.7984404628676,
        "expectedHigh": 1903.8158505915271,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 1363,
        "expectedLow": 565.8485082702606,
        "expectedHigh": 1357.2325268261918,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 2251,
        "expectedLow": 640.6443816997188,
        "expectedHigh": 1637.4762173210802,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 2227,
        "expectedLow": 592.1517299689215,
        "expectedHigh": 2333.1761187623747,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 1532,
        "expectedLow": 568.5719283060139,
        "expectedHigh": 2482.5324541174527,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 486,
        "expectedLow": 626.5220336662658,
        "expectedHigh": 2756.714518030343,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 460,
        "expectedLow": 242.45296873820536,
        "expectedHigh": 2828.989392470574,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 399,
        "expectedLow": 0,
        "expectedHigh": 2206.21138444547,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 365,
        "expectedLow": 0,
        "expectedHigh": 2298.874468494234,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "OWB (Interventional Fluoroscopic X-Ray System) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2891-2026, Z-2892-2026, Z-2893-2026, Z-2857-2026, Z-2648-2026). 5 first-time filers in the last 12 months, including Pulmera, Inc. and Cara Medical, Ltd (K252735, K252500, K251992, K251893, K251827). Clearances are running 120% slower — a median 196 days over the last 12 months against 89 days all-time (elapsed calendar days, not FDA review days) (OWB:review_time:12m). The code is crowded, scoring 91 of 100 — 107 companies hold a clearance here and 17 arrived in the last 12 months (OWB:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2891-2026",
          "Z-2892-2026",
          "Z-2893-2026",
          "Z-2857-2026",
          "Z-2648-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "5 first-time filers in the last 12 months, including Pulmera, Inc. and Cara Medical, Ltd.",
        "recordIds": [
          "K252735",
          "K252500",
          "K251992",
          "K251893",
          "K251827"
        ],
        "severity": 45
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 120% slower — a median 196 days over the last 12 months against 89 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "OWB:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 91 of 100 — 107 companies hold a clearance here and 17 arrived in the last 12 months",
        "recordIds": [
          "OWB: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%3AOWB"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AOWB"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AOWB"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AOWB"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AOWB"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AOWB"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AOWB"
    }
  ],
  "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": "2026-08-11T13:51:45.751Z"
}