{
  "code": "MOS",
  "deviceName": "Coil, Magnetic Resonance, Specialty",
  "deviceClass": "II",
  "regulationNumber": "892.1000",
  "panel": "Radiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 489,
    "last12Months": 9
  },
  "adverseEvents": {
    "total": 15,
    "last12Months": 1
  },
  "reviewDays": {
    "median": 51,
    "sampleSize": 489
  },
  "recalls": {
    "total": 38,
    "recent": [
      {
        "resNumber": "Z-0536-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America Llc",
        "reason": "Potential safety issue where a patient may be harmed while preparing for or during a scan.",
        "initiated": "2024-11-04"
      },
      {
        "resNumber": "Z-0537-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America Llc",
        "reason": "Potential safety issue where a patient may be harmed while preparing for or during a scan.",
        "initiated": "2024-11-04"
      },
      {
        "resNumber": "Z-0538-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America Llc",
        "reason": "Potential safety issue where a patient may be harmed while preparing for or during a scan.",
        "initiated": "2024-11-04"
      },
      {
        "resNumber": "Z-0539-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America Llc",
        "reason": "Potential safety issue where a patient may be harmed while preparing for or during a scan.",
        "initiated": "2024-11-04"
      },
      {
        "resNumber": "Z-0540-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America Llc",
        "reason": "Potential safety issue where a patient may be harmed while preparing for or during a scan.",
        "initiated": "2024-11-04"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K262294",
      "deviceName": "dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T",
      "applicant": "Philips Medical Systems Nederland B.V.",
      "company": "Philips Medical Systems Nederland B.V.",
      "decisionDate": "2026-07-24",
      "dateReceived": "2026-07-07"
    },
    {
      "kNumber": "K260947",
      "deviceName": "0.55T 12Ch Breast Coil",
      "applicant": "Neocoil, LLC",
      "company": "NeoCoil, LLC",
      "decisionDate": "2026-04-23",
      "dateReceived": "2026-03-23"
    },
    {
      "kNumber": "K252587",
      "deviceName": "HD 8Ch Wrist Array",
      "applicant": "Shenzhen RF Tech Co., Ltd.",
      "company": "Shenzhen RF Tech Co., Ltd.",
      "decisionDate": "2026-04-14",
      "dateReceived": "2025-08-15"
    },
    {
      "kNumber": "K252876",
      "deviceName": "GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only",
      "applicant": "Shenzhen RF Tech Co., Ltd.",
      "company": "Shenzhen RF Tech Co., Ltd.",
      "decisionDate": "2026-04-01",
      "dateReceived": "2025-09-10"
    },
    {
      "kNumber": "K260519",
      "deviceName": "Smart Fit TorsoCardiac 1.5T",
      "applicant": "Philips Healthcare (Suzhou) Co., Ltd.",
      "company": "Philips Healthcare (Suzhou) Co., Ltd.",
      "decisionDate": "2026-03-20",
      "dateReceived": "2026-02-17"
    },
    {
      "kNumber": "K252179",
      "deviceName": "GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only",
      "applicant": "Shenzhen RF Tech Co., Ltd.",
      "company": "Shenzhen RF Tech Co., Ltd.",
      "decisionDate": "2026-02-10",
      "dateReceived": "2025-07-11"
    },
    {
      "kNumber": "K253738",
      "deviceName": "3.0T AIR 32CH HNA",
      "applicant": "Ge Healthcare Coils (Usa Instruments, Inc.)",
      "company": "Ge Healthcare Coils (Usa Instruments, Inc.)",
      "decisionDate": "2026-01-23",
      "dateReceived": "2025-11-24"
    },
    {
      "kNumber": "K254190",
      "deviceName": "dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T",
      "applicant": "Philips Medical Systems Nederland B.V.",
      "company": "Philips Medical Systems Nederland B.V.",
      "decisionDate": "2026-01-14",
      "dateReceived": "2025-12-23"
    },
    {
      "kNumber": "K253182",
      "deviceName": "InkSpace Imaging Small Body Array (SBA12PH30x)",
      "applicant": "Inkspace Imaging, Inc.",
      "company": "Inkspace Imaging, Inc.",
      "decisionDate": "2025-10-20",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K243428",
      "deviceName": "e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector",
      "applicant": "Dxtx Medical, Inc.",
      "company": "Dxtx Medical, Inc.",
      "decisionDate": "2025-07-17",
      "dateReceived": "2024-11-05"
    }
  ],
  "topApplicants": [
    {
      "name": "Usa Instruments, Inc.",
      "count": 63
    },
    {
      "name": "Mri Devices Corp.",
      "count": 60
    },
    {
      "name": "Quality Electrodynamics, LLC",
      "count": 20
    },
    {
      "name": "Medical Advances, Inc.",
      "count": 19
    },
    {
      "name": "Hitachi Medical Systems America, Inc.",
      "count": 18
    }
  ],
  "topCompanies": [
    {
      "name": "Mri Devices Corporation",
      "count": 65,
      "spellings": 2
    },
    {
      "name": "USA Instruments Incorporated",
      "count": 63,
      "spellings": 1
    },
    {
      "name": "Quality Electrodynamics LLC",
      "count": 33,
      "spellings": 2
    },
    {
      "name": "Invivo Corporation",
      "count": 21,
      "spellings": 3
    },
    {
      "name": "GE Medical Systems, LLC",
      "count": 19,
      "spellings": 3
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "MOS (Coil, Magnetic Resonance, Specialty): nothing changed in the six FDA sources we watch.",
    "severity": 1,
    "factors": [],
    "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%3AMOS"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMOS"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMOS"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AMOS"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AMOS"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AMOS"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AMOS"
    }
  ],
  "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": "2026-08-11T13:51:45.745Z"
}