{
  "code": "KPS",
  "deviceName": "System, Tomography, Computed, Emission",
  "deviceClass": "II",
  "regulationNumber": "892.1200",
  "panel": "Radiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 471,
    "last12Months": 9
  },
  "adverseEvents": {
    "total": 76,
    "last12Months": 7
  },
  "reviewDays": {
    "median": 75,
    "sampleSize": 471
  },
  "recalls": {
    "total": 443,
    "recent": [
      {
        "resNumber": "Z-1112-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING",
        "firmAsPublished": "GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING",
        "reason": "There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images.  This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation).",
        "initiated": "2025-12-24"
      },
      {
        "resNumber": "Z-1045-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING",
        "firmAsPublished": "GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING",
        "reason": "GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as  Impacted Systems  and\nlisted in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.  \nThere have been no reports of detector falls or injuries as a result of this potential issue.  \nThe Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.",
        "initiated": "2025-12-10"
      },
      {
        "resNumber": "Z-1047-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING",
        "firmAsPublished": "GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING",
        "reason": "GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as  Impacted Systems  and\nlisted in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.  \nThere have been no reports of detector falls or injuries as a result of this potential issue.  \nThe Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.",
        "initiated": "2025-12-10"
      },
      {
        "resNumber": "Z-0290-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING",
        "firmAsPublished": "GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING",
        "reason": "GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.",
        "initiated": "2025-09-12"
      },
      {
        "resNumber": "Z-0291-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING",
        "firmAsPublished": "GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING",
        "reason": "GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.",
        "initiated": "2025-09-12"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261315",
      "deviceName": "Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family",
      "applicant": "Siemens Medical Solutions USA, Inc.",
      "company": "Siemens Medical Solutions USA, Inc.",
      "decisionDate": "2026-05-21",
      "dateReceived": "2026-04-21"
    },
    {
      "kNumber": "K260524",
      "deviceName": "uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)",
      "applicant": "Shanghai United Imaging Healthcare Co., Ltd.",
      "company": "Shanghai United Imaging Healthcare Co., Ltd.",
      "decisionDate": "2026-04-03",
      "dateReceived": "2026-02-17"
    },
    {
      "kNumber": "K253564",
      "deviceName": "uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)",
      "applicant": "Shanghai United Imaging Healthcare Co., Ltd.",
      "company": "Shanghai United Imaging Healthcare Co., Ltd.",
      "decisionDate": "2026-02-13",
      "dateReceived": "2025-11-17"
    },
    {
      "kNumber": "K254001",
      "deviceName": "VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)",
      "applicant": "Spectrum Dynamics Medical, Ltd.",
      "company": "Spectrum Dynamics Medical, Ltd.",
      "decisionDate": "2026-01-13",
      "dateReceived": "2025-12-15"
    },
    {
      "kNumber": "K253844",
      "deviceName": "AnyScan 3.0 NM Scanner Family",
      "applicant": "Mediso Medical Imaging Systems, Ltd.",
      "company": "Mediso Medical Imaging Systems, Ltd.",
      "decisionDate": "2025-12-30",
      "dateReceived": "2025-12-02"
    },
    {
      "kNumber": "K251370",
      "deviceName": "Cartesion Prime (PCD-1000A/3) V10.21",
      "applicant": "Canon Medical Systems Corporation",
      "company": "Canon Medical Systems Corporation",
      "decisionDate": "2025-12-01",
      "dateReceived": "2025-05-02"
    },
    {
      "kNumber": "K251401",
      "deviceName": "PennPET Explorer Positron Emission Tomograph",
      "applicant": "Trustees of the University of Pennsylvania",
      "company": "Trustees of the University of Pennsylvania",
      "decisionDate": "2025-11-25",
      "dateReceived": "2025-05-06"
    },
    {
      "kNumber": "K252477",
      "deviceName": "Hybrid Viewer (00859873006240)",
      "applicant": "Hermes Medical Solutions AB",
      "company": "Hermes Medical Solutions AB",
      "decisionDate": "2025-09-09",
      "dateReceived": "2025-08-07"
    },
    {
      "kNumber": "K250170",
      "deviceName": "PHAROS",
      "applicant": "Brightonix Imaging",
      "company": "BRIGHTONIX IMAGING INC.",
      "decisionDate": "2025-08-15",
      "dateReceived": "2025-01-21"
    },
    {
      "kNumber": "K251561",
      "deviceName": "Biograph Trinion",
      "applicant": "Siemens Medical Solutions USA, Inc.",
      "company": "Siemens Medical Solutions USA, Inc.",
      "decisionDate": "2025-07-31",
      "dateReceived": "2025-05-21"
    }
  ],
  "topApplicants": [
    {
      "name": "Siemens Medical Solutions USA, Inc.",
      "count": 46
    },
    {
      "name": "Adac Laboratories",
      "count": 35
    },
    {
      "name": "Philips Medical Systems (Cleveland), Inc.",
      "count": 20
    },
    {
      "name": "Cti Pet Systems, Inc.",
      "count": 18
    },
    {
      "name": "GE Medical Systems",
      "count": 17
    }
  ],
  "topCompanies": [
    {
      "name": "Siemens Medical Solutions USA, Inc.",
      "count": 46,
      "spellings": 1
    },
    {
      "name": "Adac Laboratories",
      "count": 35,
      "spellings": 1
    },
    {
      "name": "GE Medical Systems, LLC",
      "count": 27,
      "spellings": 3
    },
    {
      "name": "Philips Medical Systems (Cleveland), Inc.",
      "count": 20,
      "spellings": 1
    },
    {
      "name": "Cti Pet Systems, Inc.",
      "count": 18,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Mediso Medical Imaging Systems, Ltd.",
      "since": "2025-12-30",
      "kNumber": "K253844"
    },
    {
      "name": "Trustees of the University of Pennsylvania",
      "since": "2025-11-25",
      "kNumber": "K251401"
    },
    {
      "name": "BRIGHTONIX IMAGING INC.",
      "since": "2025-08-15",
      "kNumber": "K250170"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "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": "2023-04-01",
        "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": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 1,
        "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": "2024-10-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 13,
        "expectedLow": 0,
        "expectedHigh": 5.729332278556874,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 14.294318377777023,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 1,
        "expectedLow": 0,
        "expectedHigh": 13.663837542899188,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 2,
        "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
      }
    ],
    "sufficientMonths": 3,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "KPS (System, Tomography, Computed, Emission) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1112-2026, Z-1045-2026, Z-1047-2026, Z-0290-2026, Z-0291-2026). 3 first-time filers in the last 12 months, including Mediso Medical Imaging Systems, Ltd. and Trustees of the University of Pennsylvania (K253844, K251401, K250170). The code is crowded, scoring 86 of 100 — 125 companies hold a clearance here and 9 arrived in the last 12 months (KPS:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1112-2026",
          "Z-1045-2026",
          "Z-1047-2026",
          "Z-0290-2026",
          "Z-0291-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "3 first-time filers in the last 12 months, including Mediso Medical Imaging Systems, Ltd. and Trustees of the University of Pennsylvania",
        "recordIds": [
          "K253844",
          "K251401",
          "K250170"
        ],
        "severity": 43
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 86 of 100 — 125 companies hold a clearance here and 9 arrived in the last 12 months",
        "recordIds": [
          "KPS: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%3AKPS"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKPS"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKPS"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AKPS"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AKPS"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AKPS"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AKPS"
    }
  ],
  "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": "2026-08-11T13:51:45.735Z"
}