{
  "code": "JAK",
  "deviceName": "System, X-Ray, Tomography, Computed",
  "deviceClass": "II",
  "regulationNumber": "892.1750",
  "panel": "Radiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 821,
    "last12Months": 22
  },
  "adverseEvents": {
    "total": 714,
    "last12Months": 130
  },
  "reviewDays": {
    "median": 86,
    "sampleSize": 821
  },
  "recalls": {
    "total": 860,
    "recent": [
      {
        "resNumber": "Z-2650-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Philips Medical Systems, Inc.",
        "firmAsPublished": "PHILIPS MEDICAL SYSTEMS",
        "reason": "The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.",
        "initiated": "2026-06-11"
      },
      {
        "resNumber": "Z-2651-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Philips Medical Systems, Inc.",
        "firmAsPublished": "PHILIPS MEDICAL SYSTEMS",
        "reason": "The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.",
        "initiated": "2026-06-11"
      },
      {
        "resNumber": "Z-2652-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Philips Medical Systems, Inc.",
        "firmAsPublished": "PHILIPS MEDICAL SYSTEMS",
        "reason": "The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.",
        "initiated": "2026-06-11"
      },
      {
        "resNumber": "Z-2149-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GE Medical Systems, LLC",
        "firmAsPublished": "GE Medical Systems, LLC",
        "reason": "GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.",
        "initiated": "2026-03-26"
      },
      {
        "resNumber": "Z-2150-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GE Medical Systems, LLC",
        "firmAsPublished": "GE Medical Systems, LLC",
        "reason": "GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.",
        "initiated": "2026-03-26"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253770",
      "deviceName": "CardIQ Suite",
      "applicant": "GE Medical Systems SCS",
      "company": "GE Medical Systems SCS",
      "decisionDate": "2026-07-21",
      "dateReceived": "2025-11-26"
    },
    {
      "kNumber": "K253560",
      "deviceName": "Enhanced Boundary for PCCT",
      "applicant": "Ge Medical Systems, LLC",
      "company": "GE Medical Systems, LLC",
      "decisionDate": "2026-06-24",
      "dateReceived": "2025-11-17"
    },
    {
      "kNumber": "K253026",
      "deviceName": "Respiratory Gating for Scanners (2.1)",
      "applicant": "Varian Medical Systems, Inc.",
      "company": "Varian Medical Systems, Inc.",
      "decisionDate": "2026-06-04",
      "dateReceived": "2025-09-19"
    },
    {
      "kNumber": "K253596",
      "deviceName": "Aquilion ONE (TSX-308A/TSX-306A) V2.0",
      "applicant": "Canon Medical Systems Corporation",
      "company": "Canon Medical Systems Corporation",
      "decisionDate": "2026-05-20",
      "dateReceived": "2025-11-18"
    },
    {
      "kNumber": "K253649",
      "deviceName": "Spectral CT Verida Family",
      "applicant": "Philips Medical Systems Technologies , Ltd.",
      "company": "Philips Medical Systems Technologies Ltd.",
      "decisionDate": "2026-03-27",
      "dateReceived": "2025-11-20"
    },
    {
      "kNumber": "K253686",
      "deviceName": "True Definition DL",
      "applicant": "Ge Healthcare Japan Corporation",
      "company": "GE Healthcare Japan Corporation",
      "decisionDate": "2026-03-23",
      "dateReceived": "2025-11-21"
    },
    {
      "kNumber": "K252992",
      "deviceName": "CT Rembra RT; CT Areta RT; CT Rembra",
      "applicant": "Philips Healthcare (Suzhou) Co., Ltd.",
      "company": "Philips Healthcare (Suzhou) Co., Ltd.",
      "decisionDate": "2026-03-23",
      "dateReceived": "2025-09-18"
    },
    {
      "kNumber": "K253574",
      "deviceName": "SOMATOM X.cite; SOMATOM X.ceed",
      "applicant": "Siemens Medical Solutions USA, Inc.",
      "company": "Siemens Medical Solutions USA, Inc.",
      "decisionDate": "2026-03-20",
      "dateReceived": "2025-11-17"
    },
    {
      "kNumber": "K253520",
      "deviceName": "Photonova Spectra, Photonova Spectra Select",
      "applicant": "Ge Medical Systems, LLC",
      "company": "GE Medical Systems, LLC",
      "decisionDate": "2026-03-20",
      "dateReceived": "2025-11-12"
    },
    {
      "kNumber": "K260078",
      "deviceName": "Aquilion ServeSP (TSX-307B) V2.0",
      "applicant": "Canon Medical Systems Corporation",
      "company": "Canon Medical Systems Corporation",
      "decisionDate": "2026-03-13",
      "dateReceived": "2026-01-12"
    }
  ],
  "topApplicants": [
    {
      "name": "Siemens Medical Solutions USA, Inc.",
      "count": 105
    },
    {
      "name": "Toshiba America Medical Systems, In.C",
      "count": 35
    },
    {
      "name": "General Electric Co.",
      "count": 31
    },
    {
      "name": "Ge Medical Systems, LLC",
      "count": 30
    },
    {
      "name": "Toshibamedical Systems Corporation",
      "count": 27
    }
  ],
  "topCompanies": [
    {
      "name": "Siemens Medical Solutions USA, Inc.",
      "count": 105,
      "spellings": 1
    },
    {
      "name": "GE Medical Systems, LLC",
      "count": 68,
      "spellings": 3
    },
    {
      "name": "Toshiba America Medical Systems, In.C",
      "count": 35,
      "spellings": 1
    },
    {
      "name": "General Electric Company",
      "count": 31,
      "spellings": 1
    },
    {
      "name": "Toshibamedical Systems Corporation",
      "count": 27,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Mars Bioimaging , Ltd.",
      "since": "2026-03-13",
      "kNumber": "K252249"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 26,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 23,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 30,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 73,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 35,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 24,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 17,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 32,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 21,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 23,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 17,
        "expectedLow": 1.5019608782197744,
        "expectedHigh": 32.011422730038525,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 15,
        "expectedLow": 3.0314239580931472,
        "expectedHigh": 26.715899833079575,
        "isSufficient": true
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      {
        "month": "2025-03-01",
        "observed": 24,
        "expectedLow": 3.8570289602197287,
        "expectedHigh": 29.340523156833676,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 18,
        "expectedLow": 5.522304936736441,
        "expectedHigh": 33.23940627920966,
        "isSufficient": true
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      {
        "month": "2025-05-01",
        "observed": 20,
        "expectedLow": 5.301681192145335,
        "expectedHigh": 30.44477372685615,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 14,
        "expectedLow": 6.259408882575527,
        "expectedHigh": 32.52761282195332,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 15,
        "expectedLow": 12.996380237303073,
        "expectedHigh": 42.25054940901344,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 16,
        "expectedLow": 5.919119064771555,
        "expectedHigh": 29.830888687479433,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 16,
        "expectedLow": 6.4124421761337445,
        "expectedHigh": 29.944495307120636,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 26,
        "expectedLow": 7.688002494261388,
        "expectedHigh": 27.434581895304966,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 14,
        "expectedLow": 8.873002482859164,
        "expectedHigh": 27.49169649780058,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 18,
        "expectedLow": 8.37585039462181,
        "expectedHigh": 28.99665709341749,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 14,
        "expectedLow": 9.34043135948742,
        "expectedHigh": 33.30587927312692,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 19,
        "expectedLow": 5.1357696738123515,
        "expectedHigh": 27.230112349887623,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 13,
        "expectedLow": 6.73788634667934,
        "expectedHigh": 30.86443503748229,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "JAK (System, X-Ray, Tomography, Computed) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2650-2026, Z-2651-2026, Z-2652-2026, Z-2149-2026, Z-2150-2026). 1 first-time filer in the last 12 months, Mars Bioimaging , Ltd (K252249). Clearances are running 48% slower — a median 127 days over the last 12 months against 86 days all-time (elapsed calendar days, not FDA review days) (JAK:review_time:12m). The code is crowded, scoring 86 of 100 — 185 companies hold a clearance here and 22 arrived in the last 12 months (JAK:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2650-2026",
          "Z-2651-2026",
          "Z-2652-2026",
          "Z-2149-2026",
          "Z-2150-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Mars Bioimaging , Ltd.",
        "recordIds": [
          "K252249"
        ],
        "severity": 41
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 48% slower — a median 127 days over the last 12 months against 86 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "JAK:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 86 of 100 — 185 companies hold a clearance here and 22 arrived in the last 12 months",
        "recordIds": [
          "JAK: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%3AJAK"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJAK"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJAK"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJAK"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJAK"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJAK"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJAK"
    }
  ],
  "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": "2026-08-11T13:51:45.715Z"
}