{
  "code": "ITX",
  "deviceName": "Transducer, Ultrasonic, Diagnostic",
  "deviceClass": "II",
  "regulationNumber": "892.1570",
  "panel": "Radiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 410,
    "last12Months": 2
  },
  "adverseEvents": {
    "total": 1770,
    "last12Months": 362
  },
  "reviewDays": {
    "median": 106,
    "sampleSize": 410
  },
  "recalls": {
    "total": 147,
    "recent": [
      {
        "resNumber": "Z-1006-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Sheathing Technologies Inc",
        "firmAsPublished": "Sheathing Technologies Inc",
        "reason": "Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.",
        "initiated": "2025-11-17"
      },
      {
        "resNumber": "Z-1618-2026",
        "status": "Open, Classified",
        "recallClass": "Class III",
        "firm": "Philips Ultrasound, Inc.",
        "firmAsPublished": "Philips Ultrasound, Inc",
        "reason": "To provide clarification and labelling to define the useful life of ultrasound transducers in the field.",
        "initiated": "2025-09-05"
      },
      {
        "resNumber": "Z-1619-2026",
        "status": "Open, Classified",
        "recallClass": "Class III",
        "firm": "Philips Ultrasound, Inc.",
        "firmAsPublished": "Philips Ultrasound, Inc",
        "reason": "To provide clarification and labelling to define the useful life of ultrasound transducers in the field.",
        "initiated": "2025-09-05"
      },
      {
        "resNumber": "Z-1620-2026",
        "status": "Open, Classified",
        "recallClass": "Class III",
        "firm": "Philips Ultrasound, Inc.",
        "firmAsPublished": "Philips Ultrasound, Inc",
        "reason": "To provide clarification and labelling to define the useful life of ultrasound transducers in the field.",
        "initiated": "2025-09-05"
      },
      {
        "resNumber": "Z-1621-2026",
        "status": "Open, Classified",
        "recallClass": "Class III",
        "firm": "Philips Ultrasound, Inc.",
        "firmAsPublished": "Philips Ultrasound, Inc",
        "reason": "To provide clarification and labelling to define the useful life of ultrasound transducers in the field.",
        "initiated": "2025-09-05"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261014",
      "deviceName": "Accuro® 3S Needle Guide Kit",
      "applicant": "Rivanna Medical, Inc.",
      "company": "Rivanna Medical, Inc.",
      "decisionDate": "2026-07-24",
      "dateReceived": "2026-03-27"
    },
    {
      "kNumber": "K250883",
      "deviceName": "ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)",
      "applicant": "Olympus Medical Systems Corporation",
      "company": "Olympus Medical Systems Corporation",
      "decisionDate": "2025-09-18",
      "dateReceived": "2025-03-24"
    },
    {
      "kNumber": "K250762",
      "deviceName": "ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)",
      "applicant": "Olympus Medical Systems Corporation",
      "company": "Olympus Medical Systems Corporation",
      "decisionDate": "2025-07-11",
      "dateReceived": "2025-03-13"
    },
    {
      "kNumber": "K250524",
      "deviceName": "Mendaera Guidance System",
      "applicant": "Mendaera, Inc.",
      "company": "Mendaera, Inc.",
      "decisionDate": "2025-07-02",
      "dateReceived": "2025-02-21"
    },
    {
      "kNumber": "K250469",
      "deviceName": "Accuro® 3S Needle Guide Kit",
      "applicant": "Rivanna Medical, Inc.",
      "company": "Rivanna Medical, Inc.",
      "decisionDate": "2025-06-13",
      "dateReceived": "2025-02-18"
    },
    {
      "kNumber": "K241662",
      "deviceName": "Ultrasound Transducer Cover",
      "applicant": "Vitrolife Sweden AB",
      "company": "Vitrolife Sweden AB",
      "decisionDate": "2024-08-30",
      "dateReceived": "2024-06-10"
    },
    {
      "kNumber": "K233965",
      "deviceName": "UltraDrape UGPIV Barrier and Securement (34-15)",
      "applicant": "Parker Laboratories, Inc.",
      "company": "Parker Laboratories, Inc.",
      "decisionDate": "2024-08-15",
      "dateReceived": "2023-12-15"
    },
    {
      "kNumber": "K241615",
      "deviceName": "Transducer Probe Cover",
      "applicant": "Hony Medical Co., Ltd.",
      "company": "Hony Medical Co., Ltd.",
      "decisionDate": "2024-07-03",
      "dateReceived": "2024-06-05"
    },
    {
      "kNumber": "K233109",
      "deviceName": "TP Pivot Pro™ Needle Guide",
      "applicant": "Civco Medical Solutions",
      "company": "Civco Medical Solutions",
      "decisionDate": "2023-12-22",
      "dateReceived": "2023-09-27"
    },
    {
      "kNumber": "K231666",
      "deviceName": "Endoscopic Ultrasonic Probe  (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)",
      "applicant": "FUJIFILM Healthcare Americas Corporation",
      "company": "FUJIFILM Healthcare Americas Corporation",
      "decisionDate": "2023-12-13",
      "dateReceived": "2023-06-07"
    }
  ],
  "topApplicants": [
    {
      "name": "CIVCO Medical Instruments Co., Inc.",
      "count": 14
    },
    {
      "name": "Biosound, Inc.",
      "count": 13
    },
    {
      "name": "Acuson Corp.",
      "count": 11
    },
    {
      "name": "General Electric Co.",
      "count": 11
    },
    {
      "name": "Acuson Computed Sonography",
      "count": 10
    }
  ],
  "topCompanies": [
    {
      "name": "CIVCO Medical Instruments Co., Inc.",
      "count": 15,
      "spellings": 2
    },
    {
      "name": "Biosound, Inc.",
      "count": 13,
      "spellings": 1
    },
    {
      "name": "Acuson Corp.",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "General Electric Company",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "Acuson Computed Sonography",
      "count": 10,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 72,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 91,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 109,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 117,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 105,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 70,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 50,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 51,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 60,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 41,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 36,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 186,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 49,
        "expectedLow": 3.4824048251805766,
        "expectedHigh": 164.2244304311084,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 55,
        "expectedLow": 0,
        "expectedHigh": 135.64167154578197,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 40,
        "expectedLow": 0,
        "expectedHigh": 148.8861135938817,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 44,
        "expectedLow": 0,
        "expectedHigh": 143.7136689225485,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 40,
        "expectedLow": 0,
        "expectedHigh": 123.95261543765038,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 47,
        "expectedLow": 0,
        "expectedHigh": 121.28149507588282,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 44,
        "expectedLow": 0,
        "expectedHigh": 187.49112181708432,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 42,
        "expectedLow": 0,
        "expectedHigh": 135.8530393056965,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 60,
        "expectedLow": 0,
        "expectedHigh": 141.06992113979678,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 49,
        "expectedLow": 0,
        "expectedHigh": 142.5509660144181,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 38,
        "expectedLow": 0,
        "expectedHigh": 126.95657262199917,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 50,
        "expectedLow": 0,
        "expectedHigh": 139.89968032792774,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 38,
        "expectedLow": 31.689563555160937,
        "expectedHigh": 80.8064847078169,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 42,
        "expectedLow": 20.297991692247855,
        "expectedHigh": 66.0676035489234,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 52,
        "expectedLow": 28.769021202141044,
        "expectedHigh": 64.34026921581794,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "ITX (Transducer, Ultrasonic, Diagnostic) has two findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II, Class III) (Z-1006-2026, Z-1618-2026, Z-1619-2026, Z-1620-2026, Z-1621-2026). The code is crowded, scoring 66 of 100 — 174 companies hold a clearance here and 2 arrived in the last 12 months (ITX:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II, Class III)",
        "recordIds": [
          "Z-1006-2026",
          "Z-1618-2026",
          "Z-1619-2026",
          "Z-1620-2026",
          "Z-1621-2026"
        ],
        "severity": 75
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 66 of 100 — 174 companies hold a clearance here and 2 arrived in the last 12 months",
        "recordIds": [
          "ITX: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%3AITX"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AITX"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AITX"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AITX"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AITX"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AITX"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AITX"
    }
  ],
  "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": "2026-08-11T13:51:45.713Z"
}