{
  "code": "IYE",
  "deviceName": "Accelerator, Linear, Medical",
  "deviceClass": "II",
  "regulationNumber": "892.5050",
  "panel": "Radiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 734,
    "last12Months": 16
  },
  "adverseEvents": {
    "total": 283,
    "last12Months": 37
  },
  "reviewDays": {
    "median": 90,
    "sampleSize": 734
  },
  "recalls": {
    "total": 562,
    "recent": [
      {
        "resNumber": "Z-2640-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Accuray Incorporated",
        "firmAsPublished": "Accuray Incorporated",
        "reason": "In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.",
        "initiated": "2026-06-16"
      },
      {
        "resNumber": "Z-2644-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Accuray Incorporated",
        "firmAsPublished": "Accuray Incorporated",
        "reason": "In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.",
        "initiated": "2026-06-16"
      },
      {
        "resNumber": "Z-2406-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Elekta Limited",
        "firmAsPublished": "Elekta, Inc.",
        "reason": "Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.",
        "initiated": "2026-05-21"
      },
      {
        "resNumber": "Z-1164-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Elekta Limited",
        "firmAsPublished": "Elekta, Inc.",
        "reason": "Due to a manufacturing issue and electrical grounding of systems.",
        "initiated": "2025-12-14"
      },
      {
        "resNumber": "Z-1078-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Elekta Limited",
        "firmAsPublished": "Elekta, Inc.",
        "reason": "Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice",
        "initiated": "2025-12-10"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253012",
      "deviceName": "AlignRT Plus (8.0)",
      "applicant": "Vision Rt, Ltd.",
      "company": "Vision RT Ltd",
      "decisionDate": "2026-08-07",
      "dateReceived": "2025-09-19"
    },
    {
      "kNumber": "K252937",
      "deviceName": "ThinkQA 3",
      "applicant": "Dosisoft SA",
      "company": "Dosisoft SA",
      "decisionDate": "2026-06-12",
      "dateReceived": "2025-09-15"
    },
    {
      "kNumber": "K253004",
      "deviceName": "LUNA 3D",
      "applicant": "Lap GmbH Laser Applikationen",
      "company": "Lap GmbH Laser Applikationen",
      "decisionDate": "2026-06-04",
      "dateReceived": "2025-09-19"
    },
    {
      "kNumber": "K260792",
      "deviceName": "AerFrame Patient Immobilization System (AFPIS)",
      "applicant": "Stabilix, LLC",
      "company": "Stabilix, LLC",
      "decisionDate": "2026-05-08",
      "dateReceived": "2026-03-11"
    },
    {
      "kNumber": "K252258",
      "deviceName": "VERIQA RT EPID 3D",
      "applicant": "Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla",
      "company": "Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla",
      "decisionDate": "2026-04-15",
      "dateReceived": "2025-07-21"
    },
    {
      "kNumber": "K253962",
      "deviceName": "ClearCheck (RADCC V2.7)",
      "applicant": "Radformation, Inc.",
      "company": "Radformation, Inc.",
      "decisionDate": "2026-04-03",
      "dateReceived": "2025-12-11"
    },
    {
      "kNumber": "K252977",
      "deviceName": "Halcyon, Ethos Radiotherapy System (5.0)",
      "applicant": "Varian Medical Systems, Inc.",
      "company": "Varian Medical Systems, Inc.",
      "decisionDate": "2026-01-21",
      "dateReceived": "2025-09-17"
    },
    {
      "kNumber": "K252188",
      "deviceName": "EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)",
      "applicant": "Elekta Solutions AB",
      "company": "ELEKTA SOLUTIONS AB",
      "decisionDate": "2026-01-15",
      "dateReceived": "2025-07-14"
    },
    {
      "kNumber": "K254010",
      "deviceName": "ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface",
      "applicant": "Brainlab SE",
      "company": "Brainlab AG",
      "decisionDate": "2026-01-14",
      "dateReceived": "2025-12-15"
    },
    {
      "kNumber": "K252988",
      "deviceName": "ChartCheck (RADCH V1.6)",
      "applicant": "Radformation, Inc.",
      "company": "Radformation, Inc.",
      "decisionDate": "2026-01-05",
      "dateReceived": "2025-09-18"
    }
  ],
  "topApplicants": [
    {
      "name": "Varian Medical Systems, Inc.",
      "count": 69
    },
    {
      "name": "Varian Assoc., Inc.",
      "count": 27
    },
    {
      "name": "Brainlab AG",
      "count": 21
    },
    {
      "name": "Medtec, Inc.",
      "count": 20
    },
    {
      "name": "Siemens Medical Solutions USA, Inc.",
      "count": 18
    }
  ],
  "topCompanies": [
    {
      "name": "Varian Medical Systems, Inc.",
      "count": 82,
      "spellings": 2
    },
    {
      "name": "Varian Assoc., Inc.",
      "count": 27,
      "spellings": 1
    },
    {
      "name": "Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap",
      "count": 24,
      "spellings": 5
    },
    {
      "name": "Brainlab AG",
      "count": 23,
      "spellings": 3
    },
    {
      "name": "Accuray Incorporated",
      "count": 19,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Stabilix, LLC",
      "since": "2026-05-08",
      "kNumber": "K260792"
    },
    {
      "name": "Electrogenics Labs, Ltd.",
      "since": "2025-10-17",
      "kNumber": "K250911"
    },
    {
      "name": "Blessing Cathay Corporation",
      "since": "2025-09-03",
      "kNumber": "K252174"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 9,
        "expectedLow": 2.8255107303793427,
        "expectedHigh": 10.976360826217357,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 5,
        "expectedLow": 2.9071675207784584,
        "expectedHigh": 10.119929938591454,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 18,
        "expectedLow": 2.8222801924130896,
        "expectedHigh": 10.74219770625995,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 6,
        "expectedLow": 2.541473617834222,
        "expectedHigh": 18.520772982538954,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 11,
        "expectedLow": 1.0240129719727131,
        "expectedHigh": 16.08883771448351,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 18,
        "expectedLow": 1.6769586491720017,
        "expectedHigh": 17.5994615198238,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 4,
        "expectedLow": 3.9513453548734288,
        "expectedHigh": 34.39670297684962,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 6,
        "expectedLow": 0,
        "expectedHigh": 23.25168013034249,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 12,
        "expectedLow": 0,
        "expectedHigh": 22.446164586116815,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 22.67139791929675,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 4,
        "expectedLow": 0,
        "expectedHigh": 19.091403314207163,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 20.440323047008818,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 22.768387830239554,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 19.10376301607017,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 4,
        "expectedLow": 0,
        "expectedHigh": 20.730978327022,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "IYE (Accelerator, Linear, Medical) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2640-2026, Z-2644-2026, Z-2406-2026, Z-1164-2026, Z-1078-2026). 3 first-time filers in the last 12 months, including Stabilix, LLC and Electrogenics Labs, Ltd (K260792, K250911, K252174). Clearances are running 40% slower — a median 126 days over the last 12 months against 90 days all-time (elapsed calendar days, not FDA review days) (IYE:review_time:12m). The code is crowded, scoring 94 of 100 — 221 companies hold a clearance here and 16 arrived in the last 12 months (IYE:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2640-2026",
          "Z-2644-2026",
          "Z-2406-2026",
          "Z-1164-2026",
          "Z-1078-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "3 first-time filers in the last 12 months, including Stabilix, LLC and Electrogenics Labs, Ltd.",
        "recordIds": [
          "K260792",
          "K250911",
          "K252174"
        ],
        "severity": 43
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 40% slower — a median 126 days over the last 12 months against 90 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "IYE:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 94 of 100 — 221 companies hold a clearance here and 16 arrived in the last 12 months",
        "recordIds": [
          "IYE: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%3AIYE"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AIYE"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AIYE"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AIYE"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AIYE"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AIYE"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AIYE"
    }
  ],
  "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": "2026-08-11T13:51:45.714Z"
}