{
  "code": "LLZ",
  "deviceName": "System, Image Processing, Radiological",
  "deviceClass": "II",
  "regulationNumber": "892.2050",
  "panel": "Radiology",
  "definition": "A radiological image processing system.",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 2281,
    "last12Months": 52
  },
  "adverseEvents": {
    "total": 269,
    "last12Months": 179
  },
  "reviewDays": {
    "median": 78,
    "sampleSize": 2281
  },
  "recalls": {
    "total": 552,
    "recent": [
      {
        "resNumber": "Z-2874-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Merge Healthcare Incorporated",
        "firmAsPublished": "Merge Healthcare, Inc.",
        "reason": "Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.",
        "initiated": "2026-06-30"
      },
      {
        "resNumber": "Z-2875-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Merge Healthcare Incorporated",
        "firmAsPublished": "Merge Healthcare, Inc.",
        "reason": "Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.",
        "initiated": "2026-06-30"
      },
      {
        "resNumber": "Z-2771-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Boston Scientific Corporation",
        "firmAsPublished": "Boston Scientific Corporation",
        "reason": "Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects \"Recalculate\",  the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.",
        "initiated": "2026-06-19"
      },
      {
        "resNumber": "Z-2553-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GE Medical Systems SCS",
        "firmAsPublished": "GE Medical Systems SCS",
        "reason": "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one.  When this issue occurs, there is no system warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment.",
        "initiated": "2026-05-08"
      },
      {
        "resNumber": "Z-1805-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips Medical Systems Nederland B.V.",
        "firmAsPublished": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.",
        "reason": "Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.",
        "initiated": "2026-03-19"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K262462",
      "deviceName": "TheraSphere 360™ Y-90 Management Platform",
      "applicant": "Boston Scientific Corporation",
      "company": "Boston Scientific Corporation",
      "decisionDate": "2026-07-24",
      "dateReceived": "2026-07-17"
    },
    {
      "kNumber": "K262143",
      "deviceName": "ImageGrid StreamVue",
      "applicant": "Candelis, Inc.",
      "company": "Candelis, Inc.",
      "decisionDate": "2026-07-23",
      "dateReceived": "2026-06-25"
    },
    {
      "kNumber": "K260500",
      "deviceName": "ResolutionMD",
      "applicant": "ResolutionMD, Inc.",
      "company": "ResolutionMD, Inc.",
      "decisionDate": "2026-07-21",
      "dateReceived": "2026-02-13"
    },
    {
      "kNumber": "K262120",
      "deviceName": "Avara Viewer",
      "applicant": "Avara Software",
      "company": "Avara Software",
      "decisionDate": "2026-07-10",
      "dateReceived": "2026-06-23"
    },
    {
      "kNumber": "K253899",
      "deviceName": "3D-Anywhere",
      "applicant": "Provect.AI",
      "company": "Provect.AI",
      "decisionDate": "2026-07-09",
      "dateReceived": "2025-12-05"
    },
    {
      "kNumber": "K261465",
      "deviceName": "INDIRA CLOUD VIEWER",
      "applicant": "INDIGO TECHNOLOGIES",
      "company": "INDIGO TECHNOLOGIES",
      "decisionDate": "2026-07-06",
      "dateReceived": "2026-05-04"
    },
    {
      "kNumber": "K260576",
      "deviceName": "MeVis AVM Contour",
      "applicant": "MeVis Medical Solutions AG",
      "company": "MeVis Medical Solutions AG",
      "decisionDate": "2026-06-30",
      "dateReceived": "2026-02-20"
    },
    {
      "kNumber": "K260231",
      "deviceName": "MiPACS V5 (1.0.0)",
      "applicant": "Apryse Software Corp",
      "company": "Apryse Software Corp.",
      "decisionDate": "2026-06-25",
      "dateReceived": "2026-01-26"
    },
    {
      "kNumber": "K253421",
      "deviceName": "Perfusion Measurement Platform v1",
      "applicant": "Quantified Imaging Limited",
      "company": "Quantified Imaging Limited",
      "decisionDate": "2026-06-22",
      "dateReceived": "2025-10-01"
    },
    {
      "kNumber": "K261352",
      "deviceName": "2D Hip Planning Software",
      "applicant": "One Ortho",
      "company": "One Ortho",
      "decisionDate": "2026-06-08",
      "dateReceived": "2026-04-24"
    }
  ],
  "topApplicants": [
    {
      "name": "Siemens Medical Solutions USA, Inc.",
      "count": 74
    },
    {
      "name": "Totoku Electric Co., Ltd.",
      "count": 40
    },
    {
      "name": "Barco N.V.",
      "count": 37
    },
    {
      "name": "Eizo Nanao Corporation",
      "count": 34
    },
    {
      "name": "Vital Images, Inc.",
      "count": 34
    }
  ],
  "topCompanies": [
    {
      "name": "Siemens Medical Solutions USA, Inc.",
      "count": 74,
      "spellings": 1
    },
    {
      "name": "Totoku Electric Co., Ltd.",
      "count": 40,
      "spellings": 1
    },
    {
      "name": "Barco N.V.",
      "count": 37,
      "spellings": 1
    },
    {
      "name": "Eizo Nanao Corporation",
      "count": 34,
      "spellings": 1
    },
    {
      "name": "Vital Images, Inc.",
      "count": 34,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "ResolutionMD, Inc.",
      "since": "2026-07-21",
      "kNumber": "K260500"
    },
    {
      "name": "Avara Software",
      "since": "2026-07-10",
      "kNumber": "K262120"
    },
    {
      "name": "Provect.AI",
      "since": "2026-07-09",
      "kNumber": "K253899"
    },
    {
      "name": "INDIGO TECHNOLOGIES",
      "since": "2026-07-06",
      "kNumber": "K261465"
    },
    {
      "name": "Apryse Software Corp.",
      "since": "2026-06-25",
      "kNumber": "K260231"
    },
    {
      "name": "Quantified Imaging Limited",
      "since": "2026-06-22",
      "kNumber": "K253421"
    },
    {
      "name": "One Ortho",
      "since": "2026-06-08",
      "kNumber": "K261352"
    },
    {
      "name": "Customed, Inc",
      "since": "2026-06-03",
      "kNumber": "K260116"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-05-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 1,
        "expectedLow": 0,
        "expectedHigh": 21.425907475391824,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 4,
        "expectedLow": 0,
        "expectedHigh": 15.436242564823884,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 13,
        "expectedLow": 0,
        "expectedHigh": 16.44095982457709,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 44,
        "expectedLow": 0,
        "expectedHigh": 19.56815338891059,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 38.54486346019729,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 20,
        "expectedLow": 0,
        "expectedHigh": 39.56835408495502,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 21,
        "expectedLow": 0,
        "expectedHigh": 47.46261188247135,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 10,
        "expectedLow": 0,
        "expectedHigh": 40.43889284321083,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 60,
        "expectedLow": 0,
        "expectedHigh": 41.61960653516689,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 9,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "LLZ (System, Image Processing, Radiological) has five findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2874-2026, Z-2875-2026, Z-2771-2026, Z-2553-2026, Z-1805-2026). Adverse events reported in 2026-03 ran high — 60 reports against an expected 0 to 42 (LLZ:MAUDE:2026-03). 27 first-time filers in the last 12 months, including ResolutionMD, Inc. and Avara Software (K260500, K262120, K253899, K261465, K260231). Clearances are running 82% slower — a median 142 days over the last 12 months against 78 days all-time (elapsed calendar days, not FDA review days) (LLZ:review_time:12m). The code is crowded, scoring 100 of 100 — 985 companies hold a clearance here and 52 arrived in the last 12 months (LLZ:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2874-2026",
          "Z-2875-2026",
          "Z-2771-2026",
          "Z-2553-2026",
          "Z-1805-2026"
        ],
        "severity": 75
      },
      {
        "kind": "spike",
        "detail": "adverse events reported in 2026-03 ran high — 60 reports against an expected 0 to 42",
        "recordIds": [
          "LLZ:MAUDE:2026-03"
        ],
        "severity": 63
      },
      {
        "kind": "new_entrant",
        "detail": "27 first-time filers in the last 12 months, including ResolutionMD, Inc. and Avara Software",
        "recordIds": [
          "K260500",
          "K262120",
          "K253899",
          "K261465",
          "K260231"
        ],
        "severity": 50
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 82% slower — a median 142 days over the last 12 months against 78 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "LLZ:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 100 of 100 — 985 companies hold a clearance here and 52 arrived in the last 12 months",
        "recordIds": [
          "LLZ: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%3ALLZ"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALLZ"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALLZ"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ALLZ"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ALLZ"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ALLZ"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ALLZ"
    }
  ],
  "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"
}