{
  "code": "LNH",
  "deviceName": "System, Nuclear Magnetic Resonance Imaging",
  "deviceClass": "II",
  "regulationNumber": "892.1000",
  "panel": "Radiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 1099,
    "last12Months": 22
  },
  "adverseEvents": {
    "total": 1657,
    "last12Months": 356
  },
  "reviewDays": {
    "median": 86,
    "sampleSize": 1099
  },
  "recalls": {
    "total": 699,
    "recent": [
      {
        "resNumber": "Z-1951-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America",
        "reason": "The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.",
        "initiated": "2026-04-14"
      },
      {
        "resNumber": "Z-1952-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America",
        "reason": "The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.",
        "initiated": "2026-04-14"
      },
      {
        "resNumber": "Z-1953-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America",
        "reason": "The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.",
        "initiated": "2026-04-14"
      },
      {
        "resNumber": "Z-1954-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America",
        "reason": "The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.",
        "initiated": "2026-04-14"
      },
      {
        "resNumber": "Z-1955-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America",
        "reason": "The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.",
        "initiated": "2026-04-14"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K260113",
      "deviceName": "uMR Astra",
      "applicant": "Shanghai United Imaging Healthcare Co., Ltd.",
      "company": "Shanghai United Imaging Healthcare Co., Ltd.",
      "decisionDate": "2026-05-22",
      "dateReceived": "2026-01-14"
    },
    {
      "kNumber": "K253862",
      "deviceName": "APERTO Lucent MRI System",
      "applicant": "Fujifilm Corporation",
      "company": "Fujifilm Corporation",
      "decisionDate": "2026-04-06",
      "dateReceived": "2025-12-03"
    },
    {
      "kNumber": "K260746",
      "deviceName": "S-scan Open (100001800)",
      "applicant": "Esaote, S.p.A.",
      "company": "ESAOTE S.P.A.",
      "decisionDate": "2026-03-27",
      "dateReceived": "2026-03-06"
    },
    {
      "kNumber": "K253625",
      "deviceName": "Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR",
      "applicant": "Canon Medical Systems Corporation",
      "company": "Canon Medical Systems Corporation",
      "decisionDate": "2026-03-27",
      "dateReceived": "2025-11-18"
    },
    {
      "kNumber": "K251937",
      "deviceName": "nordicAudio (1.0)",
      "applicant": "Nordicneurolab AS",
      "company": "NordicNeuroLab AS",
      "decisionDate": "2026-03-20",
      "dateReceived": "2025-06-24"
    },
    {
      "kNumber": "K254277",
      "deviceName": "Embrace Neonatal MRI System",
      "applicant": "Aspect Imaging, Ltd.",
      "company": "Aspect Imaging, Ltd.",
      "decisionDate": "2026-03-13",
      "dateReceived": "2025-12-30"
    },
    {
      "kNumber": "K253413",
      "deviceName": "LiverMultiScan (v6.0)",
      "applicant": "Perspectum, Ltd.",
      "company": "Perspectum, Ltd.",
      "decisionDate": "2026-03-09",
      "dateReceived": "2025-10-01"
    },
    {
      "kNumber": "K251901",
      "deviceName": "Magnifico Open (100009900)",
      "applicant": "Esaote, S.p.A.",
      "company": "ESAOTE S.P.A.",
      "decisionDate": "2026-03-05",
      "dateReceived": "2025-06-20"
    },
    {
      "kNumber": "K260265",
      "deviceName": "MAGNETOM Flow.Ace; MAGNETOM Flow.Plus",
      "applicant": "Siemens Shenzhen Magnetic Resonance , Ltd.",
      "company": "Siemens Shenzhen Magnetic Resonance , Ltd.",
      "decisionDate": "2026-02-23",
      "dateReceived": "2026-01-28"
    },
    {
      "kNumber": "K253648",
      "deviceName": "Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades",
      "applicant": "Philips Medical Systems Nederland B.V.",
      "company": "Philips Medical Systems Nederland B.V.",
      "decisionDate": "2026-02-23",
      "dateReceived": "2025-11-20"
    }
  ],
  "topApplicants": [
    {
      "name": "Siemens Medical Solutions USA, Inc.",
      "count": 135
    },
    {
      "name": "Toshiba America Mri, Inc.",
      "count": 62
    },
    {
      "name": "Philips Medical Systems (Cleveland), Inc.",
      "count": 57
    },
    {
      "name": "Hitachi Medical Systems America, Inc.",
      "count": 54
    },
    {
      "name": "GE Medical Systems",
      "count": 39
    }
  ],
  "topCompanies": [
    {
      "name": "Siemens Medical Solutions USA, Inc.",
      "count": 135,
      "spellings": 1
    },
    {
      "name": "GE Medical Systems, LLC",
      "count": 81,
      "spellings": 3
    },
    {
      "name": "Toshiba America Mri, Inc.",
      "count": 62,
      "spellings": 1
    },
    {
      "name": "Philips Medical Systems (Cleveland), Inc.",
      "count": 57,
      "spellings": 1
    },
    {
      "name": "Hitachi Medical Systems America Inc",
      "count": 54,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Eyas Medical Imaging, Inc.",
      "since": "2026-01-26",
      "kNumber": "K253499"
    },
    {
      "name": "Fujifilm Corporation",
      "since": "2025-09-17",
      "kNumber": "K251386"
    },
    {
      "name": "Vista AI, Inc.",
      "since": "2025-08-21",
      "kNumber": "K251029"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 32,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
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        "month": "2024-10-01",
        "observed": 38,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 63,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 54,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
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        "month": "2025-01-01",
        "observed": 286,
        "expectedLow": 3.3155298017328705,
        "expectedHigh": 71.53422106534846,
        "isSufficient": true
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      {
        "month": "2025-02-01",
        "observed": 187,
        "expectedLow": 0,
        "expectedHigh": 233.01705370241052,
        "isSufficient": true
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      {
        "month": "2025-03-01",
        "observed": 146,
        "expectedLow": 0,
        "expectedHigh": 316.1022273209517,
        "isSufficient": true
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        "month": "2025-04-01",
        "observed": 105,
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        "expectedHigh": 332.3263019768336,
        "isSufficient": true
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      {
        "month": "2025-05-01",
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        "expectedHigh": 297.33039681589736,
        "isSufficient": true
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      {
        "month": "2025-06-01",
        "observed": 48,
        "expectedLow": 0,
        "expectedHigh": 283.3377338954653,
        "isSufficient": true
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      {
        "month": "2025-07-01",
        "observed": 58,
        "expectedLow": 0,
        "expectedHigh": 408.8703884505435,
        "isSufficient": true
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      {
        "month": "2025-08-01",
        "observed": 55,
        "expectedLow": 0,
        "expectedHigh": 284.9596080006267,
        "isSufficient": true
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      {
        "month": "2025-09-01",
        "observed": 48,
        "expectedLow": 0,
        "expectedHigh": 284.3368113308497,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 61,
        "expectedLow": 0,
        "expectedHigh": 270.57049753777625,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 38,
        "expectedLow": 0,
        "expectedHigh": 238.93235230420996,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 61,
        "expectedLow": 0,
        "expectedHigh": 259.59654174638877,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 36,
        "expectedLow": 0,
        "expectedHigh": 303.92089251794636,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 40,
        "expectedLow": 0,
        "expectedHigh": 186.93352029081126,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 33,
        "expectedLow": 0,
        "expectedHigh": 144.36185082738592,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "LNH (System, Nuclear Magnetic Resonance Imaging) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1951-2026, Z-1952-2026, Z-1953-2026, Z-1954-2026, Z-1955-2026). 3 first-time filers in the last 12 months, including Eyas Medical Imaging, Inc. and Fujifilm Corporation (K253499, K251386, K251029). Clearances are running 22% slower — a median 105 days over the last 12 months against 86 days all-time (elapsed calendar days, not FDA review days) (LNH:review_time:12m). The code is crowded, scoring 94 of 100 — 197 companies hold a clearance here and 22 arrived in the last 12 months (LNH:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1951-2026",
          "Z-1952-2026",
          "Z-1953-2026",
          "Z-1954-2026",
          "Z-1955-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "3 first-time filers in the last 12 months, including Eyas Medical Imaging, Inc. and Fujifilm Corporation",
        "recordIds": [
          "K253499",
          "K251386",
          "K251029"
        ],
        "severity": 43
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 22% slower — a median 105 days over the last 12 months against 86 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "LNH:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 94 of 100 — 197 companies hold a clearance here and 22 arrived in the last 12 months",
        "recordIds": [
          "LNH: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%3ALNH"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALNH"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALNH"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ALNH"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ALNH"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ALNH"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ALNH"
    }
  ],
  "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": "2026-08-11T13:51:45.739Z"
}