{
  "code": "GWQ",
  "deviceName": "Full-Montage Standard Electroencephalograph",
  "deviceClass": "II",
  "regulationNumber": "882.1400",
  "panel": "Neurology",
  "definition": "Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 189,
    "last12Months": 2
  },
  "adverseEvents": {
    "total": 54,
    "last12Months": 17
  },
  "reviewDays": {
    "median": 107,
    "sampleSize": 189
  },
  "recalls": {
    "total": 23,
    "recent": [
      {
        "resNumber": "Z-2353-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Micromed S.p.A.",
        "firmAsPublished": "Micromed S.p.A.",
        "reason": "Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 were displayed with a shift of 1 second between the 64channels blocks. In rare circumstances, a fixed 1-second temporal delay may appear between two 64-channel modules with firmware 2021.02, 2022.01 or 2022.02 in a multi-module SEEG configuration, potentially leading to misinterpretation of results.",
        "initiated": "2026-05-04"
      },
      {
        "resNumber": "Z-2138-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Natus Neurology Incorporated",
        "firmAsPublished": "Natus Neurology DBA Excel Tech., Ltd. (XLTEK)",
        "reason": "Natus received two complaints of left side labeling show impedance for right side.",
        "initiated": "2025-06-18"
      },
      {
        "resNumber": "Z-3143-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "SEER MEDICAL PTY LTD",
        "firmAsPublished": "SEER MEDICAL PTY LTD",
        "reason": "During CAPA investigations of sight production inconsistencies, it was highlighted that previous Electromagnetic Compatibility (EMC) assessments related to RF radiated emissions may not be reasonably equivalent to the current product due to design changes in the system. A new CAPA was opened to investigate the radiated emissions compliance issues.\n- Seer Home Systems distributed and retained in the field were not compliant with Electromagnetic Compatibility (EMC) testing according to IEC 60601-1-2\n- Seer Home Systems, including accessories, were manufactured and distributed without application of proper design change and manufacturing controls\n- Seer Home Systems were distributed with labeling deficiencies",
        "initiated": "2024-08-12"
      },
      {
        "resNumber": "Z-1942-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "WAVi Co.",
        "firmAsPublished": "WAVi Co.",
        "reason": "Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.",
        "initiated": "2023-12-08"
      },
      {
        "resNumber": "Z-0865-2021",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Nihon Kohden America Inc",
        "firmAsPublished": "Nihon Kohden America Inc",
        "reason": "Medical device non-conformance to electrical safety standard (IEC 60601-1).",
        "initiated": "2020-12-21"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261604",
      "deviceName": "Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)",
      "applicant": "Neuroelectrics Barcelona S.L.U.",
      "company": "Neuroelectrics Barcelona S.L.U.",
      "decisionDate": "2026-06-13",
      "dateReceived": "2026-05-14"
    },
    {
      "kNumber": "K260455",
      "deviceName": "New Wave System",
      "applicant": "Zeto, Inc.",
      "company": "Zeto, Inc.",
      "decisionDate": "2026-03-13",
      "dateReceived": "2026-02-11"
    },
    {
      "kNumber": "K233403",
      "deviceName": "Flexset System",
      "applicant": "Zeto, Inc.",
      "company": "Zeto, Inc.",
      "decisionDate": "2024-04-30",
      "dateReceived": "2023-10-04"
    },
    {
      "kNumber": "K231366",
      "deviceName": "Neuronaute Plus",
      "applicant": "Bioserenity Sas",
      "company": "Bioserenity Sas",
      "decisionDate": "2023-11-09",
      "dateReceived": "2023-05-11"
    },
    {
      "kNumber": "K221959",
      "deviceName": "Q21",
      "applicant": "Neurofield, Inc.",
      "company": "Neurofield, Inc.",
      "decisionDate": "2023-08-31",
      "dateReceived": "2022-07-05"
    },
    {
      "kNumber": "K231457",
      "deviceName": "SPARK Scan",
      "applicant": "Spark Neuro, Inc.",
      "company": "Spark Neuro, Inc.",
      "decisionDate": "2023-08-18",
      "dateReceived": "2023-05-19"
    },
    {
      "kNumber": "K221963",
      "deviceName": "Cumulus Functional Neurophysiology Platform",
      "applicant": "Cumulus Neuroscience Limited",
      "company": "Cumulus Neuroscience Limited",
      "decisionDate": "2023-04-27",
      "dateReceived": "2022-07-05"
    },
    {
      "kNumber": "K230073",
      "deviceName": "Okti",
      "applicant": "Compumedics Limited",
      "company": "Compumedics Limited",
      "decisionDate": "2023-02-09",
      "dateReceived": "2023-01-10"
    },
    {
      "kNumber": "K223644",
      "deviceName": "Neuronaute with IceCap 2 & IceCap 2 Small",
      "applicant": "Bioserenity",
      "company": "Bioserenity Sas",
      "decisionDate": "2023-01-12",
      "dateReceived": "2022-12-06"
    },
    {
      "kNumber": "K220056",
      "deviceName": "iSyncWave",
      "applicant": "iMediSync, Inc.",
      "company": "iMediSync, Inc.",
      "decisionDate": "2022-08-10",
      "dateReceived": "2022-01-06"
    }
  ],
  "topApplicants": [
    {
      "name": "Excel Tech. , Ltd.",
      "count": 15
    },
    {
      "name": "Nihon Kohden America, Inc.",
      "count": 15
    },
    {
      "name": "Del Mar Avionics",
      "count": 7
    },
    {
      "name": "Oxford Medilog, Inc.",
      "count": 6
    },
    {
      "name": "Bio-Logic Systems Corp.",
      "count": 5
    }
  ],
  "topCompanies": [
    {
      "name": "Excel Tech. , Ltd.",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "Nihon Kohden America Inc",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "Del Mar Avionics",
      "count": 7,
      "spellings": 1
    },
    {
      "name": "Natus Medical Incorporated",
      "count": 6,
      "spellings": 3
    },
    {
      "name": "Oxford Medilog, Inc.",
      "count": 6,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "GWQ (Full-Montage Standard Electroencephalograph) has one finding. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-2353-2026).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2353-2026"
        ],
        "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%3AGWQ"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AGWQ"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AGWQ"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AGWQ"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AGWQ"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AGWQ"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AGWQ"
    }
  ],
  "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": "2026-08-11T13:51:45.704Z"
}