{
  "code": "JAQ",
  "deviceName": "System, Applicator, Radionuclide, Remote-Controlled",
  "deviceClass": "II",
  "regulationNumber": "892.5700",
  "panel": "Radiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 208,
    "last12Months": 4
  },
  "adverseEvents": {
    "total": 10,
    "last12Months": 6
  },
  "reviewDays": {
    "median": 99,
    "sampleSize": 208
  },
  "recalls": {
    "total": 52,
    "recent": [
      {
        "resNumber": "Z-2710-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Elekta Limited",
        "firmAsPublished": "Elekta, Inc.",
        "reason": "Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.",
        "initiated": "2026-04-03"
      },
      {
        "resNumber": "Z-2711-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Elekta Limited",
        "firmAsPublished": "Elekta, Inc.",
        "reason": "Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.",
        "initiated": "2026-04-03"
      },
      {
        "resNumber": "Z-2712-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Elekta Limited",
        "firmAsPublished": "Elekta, Inc.",
        "reason": "Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.",
        "initiated": "2026-04-03"
      },
      {
        "resNumber": "Z-0772-2020",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Nucletron BV",
        "firmAsPublished": "Nucletron BV",
        "reason": "A component failure may lead to treatment interruption or incorrect source positioning.",
        "initiated": "2019-11-18"
      },
      {
        "resNumber": "Z-1829-2015",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Varian Medical Systems, Inc.",
        "firmAsPublished": "Varian Medical Systems Inc",
        "reason": "Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surface Applicator's Instructions for Use (IFU): Dose Characterization\nGM11010080 2012-09-06. \n\nThe actual dose rate of the applicator is approximately 14% higher than the rate published within the IFU. Use of the dose rate as provided by the IFU without modification or independent confirmat",
        "initiated": "2015-05-18"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K262383",
      "deviceName": "LumenCare Azure",
      "applicant": "Nucletron B.V.",
      "company": "Nucletron B.V.",
      "decisionDate": "2026-07-24",
      "dateReceived": "2026-07-13"
    },
    {
      "kNumber": "K252717",
      "deviceName": "MAASTRO Rectal Applicator Set",
      "applicant": "Varian Medical Systems",
      "company": "Varian Medical Systems, Inc.",
      "decisionDate": "2026-05-20",
      "dateReceived": "2025-08-28"
    },
    {
      "kNumber": "K251037",
      "deviceName": "Rectal Applicator",
      "applicant": "Nucletron B.V.",
      "company": "Nucletron B.V.",
      "decisionDate": "2025-12-19",
      "dateReceived": "2025-04-03"
    },
    {
      "kNumber": "K252884",
      "deviceName": "Guided Aarhus Applicator Set",
      "applicant": "Varian Medical Systems",
      "company": "Varian Medical Systems, Inc.",
      "decisionDate": "2025-11-19",
      "dateReceived": "2025-09-10"
    },
    {
      "kNumber": "K250299",
      "deviceName": "CT/ MR Tandem and Ovoid Set",
      "applicant": "Varian Medical Systems, Inc.",
      "company": "Varian Medical Systems, Inc.",
      "decisionDate": "2025-05-09",
      "dateReceived": "2025-01-31"
    },
    {
      "kNumber": "K250289",
      "deviceName": "Intracavitary/Interstitial System",
      "applicant": "Varian Medical Systems",
      "company": "Varian Medical Systems, Inc.",
      "decisionDate": "2025-04-25",
      "dateReceived": "2025-01-31"
    },
    {
      "kNumber": "K243939",
      "deviceName": "Titanium Flexible Geometry FSD Applicator Set (GM11013400)",
      "applicant": "Varian Medical Systems, Inc.",
      "company": "Varian Medical Systems, Inc.",
      "decisionDate": "2025-03-03",
      "dateReceived": "2024-12-20"
    },
    {
      "kNumber": "K241764",
      "deviceName": "Mould Probe MR Safe",
      "applicant": "Varian Medical Systems, Inc.",
      "company": "Varian Medical Systems, Inc.",
      "decisionDate": "2025-01-10",
      "dateReceived": "2024-06-20"
    },
    {
      "kNumber": "K242961",
      "deviceName": "Intraluminal Applicator Set",
      "applicant": "Varian Medical Systems",
      "company": "Varian Medical Systems, Inc.",
      "decisionDate": "2024-11-26",
      "dateReceived": "2024-09-25"
    },
    {
      "kNumber": "K243045",
      "deviceName": "“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)",
      "applicant": "Braxx Biotech Co., Ltd.",
      "company": "Braxx Biotech Co., Ltd.",
      "decisionDate": "2024-11-19",
      "dateReceived": "2024-09-27"
    }
  ],
  "topApplicants": [
    {
      "name": "Varian Medical Systems, Inc.",
      "count": 50
    },
    {
      "name": "Mick Radio-Nuclear Instruments, Inc.",
      "count": 22
    },
    {
      "name": "Nucletron Corp.",
      "count": 14
    },
    {
      "name": "Nucletron Corporation",
      "count": 10
    },
    {
      "name": "Nucletron B.V.",
      "count": 9
    }
  ],
  "topCompanies": [
    {
      "name": "Varian Medical Systems, Inc.",
      "count": 59,
      "spellings": 2
    },
    {
      "name": "Nucletron BV",
      "count": 26,
      "spellings": 3
    },
    {
      "name": "Mick Radio-Nuclear Instruments, Inc.",
      "count": 22,
      "spellings": 1
    },
    {
      "name": "Nucletron B.V.",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Nucletron-Oldelft Corp.",
      "count": 7,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "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": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "JAQ (System, Applicator, Radionuclide, Remote-Controlled) has one finding. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2710-2026, Z-2711-2026, Z-2712-2026).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "3 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2710-2026",
          "Z-2711-2026",
          "Z-2712-2026"
        ],
        "severity": 75
      }
    ],
    "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%3AJAQ"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJAQ"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJAQ"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJAQ"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJAQ"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJAQ"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJAQ"
    }
  ],
  "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": "2026-08-11T13:51:45.716Z"
}