{
  "code": "IZI",
  "deviceName": "System, X-Ray, Angiographic",
  "deviceClass": "II",
  "regulationNumber": "892.1600",
  "panel": "Radiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 199,
    "last12Months": 3
  },
  "adverseEvents": {
    "total": 4685,
    "last12Months": 1487
  },
  "reviewDays": {
    "median": 79,
    "sampleSize": 199
  },
  "recalls": {
    "total": 259,
    "recent": [
      {
        "resNumber": "Z-2411-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips Medical Systems Nederland B.V.",
        "firmAsPublished": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.",
        "reason": "Philips Allura Xper and MultiDiagnost-Eleva systems\nHand switch button not fully releasing potentially leading to loss of imaging functionality or unintended\nradiation exposure and additional contrast injection",
        "initiated": "2026-05-18"
      },
      {
        "resNumber": "Z-0654-2022",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Shimadzu Medical Systems",
        "firmAsPublished": "Shimadzu Medical Systems",
        "reason": "Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.",
        "initiated": "2021-12-16"
      },
      {
        "resNumber": "Z-0554-2021",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Shimadzu Medical Systems",
        "firmAsPublished": "Shimadzu Medical Systems",
        "reason": "The firm has identified a problem with the control software for the celling arm of the X-Ray System .  This software issue could cause the  ceiling arm of the device to move after the operator has released the  movement lever. This could result in possible collision or harm to the patient or system operator.",
        "initiated": "2020-11-18"
      },
      {
        "resNumber": "Z-0556-2021",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Shimadzu Medical Systems",
        "firmAsPublished": "Shimadzu Medical Systems",
        "reason": "The firm has identified a problem with the control software for the celling arm of the X-Ray System .  This software issue could cause the  ceiling arm of the device to move after the operator has released the  movement lever. This could result in possible collision or harm to the patient or system operator.",
        "initiated": "2020-11-18"
      },
      {
        "resNumber": "Z-1489-2020",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North  America, LLC",
        "reason": "A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.",
        "initiated": "2019-12-30"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261037",
      "deviceName": "780 nm SPY Portable Handheld Imaging (SPY-PHI) System",
      "applicant": "Stryker Endoscopy",
      "company": "Stryker Endoscopy",
      "decisionDate": "2026-05-28",
      "dateReceived": "2026-03-30"
    },
    {
      "kNumber": "K253181",
      "deviceName": "SURGIMAGE SIM 1000H Fluorescence Imaging Platform",
      "applicant": "Surgimage Corporation",
      "company": "Surgimage Corporation",
      "decisionDate": "2026-05-13",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K243645",
      "deviceName": "IC-Flow™ Imaging System 2.0",
      "applicant": "Diagnostic Green GmbH",
      "company": "Diagnostic Green GmbH",
      "decisionDate": "2025-09-22",
      "dateReceived": "2024-11-26"
    },
    {
      "kNumber": "K243077",
      "deviceName": "Affirm 800",
      "applicant": "Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)",
      "company": "Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)",
      "decisionDate": "2025-06-27",
      "dateReceived": "2024-09-30"
    },
    {
      "kNumber": "K231986",
      "deviceName": "Modus IR",
      "applicant": "Synaptive Medical, Inc.",
      "company": "Synaptive Medical, Inc.",
      "decisionDate": "2024-03-25",
      "dateReceived": "2023-07-05"
    },
    {
      "kNumber": "K234090",
      "deviceName": "EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)",
      "applicant": "Surgvision GmbH",
      "company": "Surgvision GmbH",
      "decisionDate": "2024-03-20",
      "dateReceived": "2023-12-22"
    },
    {
      "kNumber": "K231075",
      "deviceName": "Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)",
      "applicant": "Carl Zeiss Meditec, Inc.",
      "company": "Carl Zeiss Meditec, Inc.",
      "decisionDate": "2023-06-20",
      "dateReceived": "2023-04-14"
    },
    {
      "kNumber": "K230727",
      "deviceName": "SPY Portable Handheld Imaging (SPY-PHI) System",
      "applicant": "Novadaq Technologies Ulc (A Part of Stryker)",
      "company": "Novadaq Technologies Ulc (A Part of Stryker)",
      "decisionDate": "2023-06-05",
      "dateReceived": "2023-03-16"
    },
    {
      "kNumber": "K222240",
      "deviceName": "EXPLORER AIR® II",
      "applicant": "Surgvision GmbH",
      "company": "Surgvision GmbH",
      "decisionDate": "2023-02-28",
      "dateReceived": "2022-07-26"
    },
    {
      "kNumber": "K214097",
      "deviceName": "Explorer Air II",
      "applicant": "Surgvision GmbH",
      "company": "Surgvision GmbH",
      "decisionDate": "2022-02-25",
      "dateReceived": "2021-12-28"
    }
  ],
  "topApplicants": [
    {
      "name": "Siemens Medical Solutions USA, Inc.",
      "count": 13
    },
    {
      "name": "Xre Corp.",
      "count": 10
    },
    {
      "name": "Novadaq Technologies, Inc.",
      "count": 9
    },
    {
      "name": "GE Medical Systems",
      "count": 8
    },
    {
      "name": "Shimadzu Medical Systems",
      "count": 8
    }
  ],
  "topCompanies": [
    {
      "name": "Siemens Medical Solutions USA, Inc.",
      "count": 13,
      "spellings": 1
    },
    {
      "name": "GE Medical Systems, LLC",
      "count": 10,
      "spellings": 2
    },
    {
      "name": "Xre Corp.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Novadaq Technologies, Inc.",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Philips Medical Systems North America Inc.",
      "count": 9,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Stryker Endoscopy",
      "since": "2026-05-28",
      "kNumber": "K261037"
    },
    {
      "name": "Surgimage Corporation",
      "since": "2026-05-13",
      "kNumber": "K253181"
    },
    {
      "name": "Diagnostic Green GmbH",
      "since": "2025-09-22",
      "kNumber": "K243645"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 131,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 87,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 166,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 58,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 96,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 85,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 73,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 67,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 83,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 190,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 156,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 95,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 78,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 81,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 49,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 85,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 107,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 112,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 128,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 126,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 125,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 95,
        "expectedLow": 34.7850478548835,
        "expectedHigh": 178.61228396798893,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 88,
        "expectedLow": 44.431434054071055,
        "expectedHigh": 134.5985736662368,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 114,
        "expectedLow": 62.0602995035652,
        "expectedHigh": 135.69921761110655,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 197,
        "expectedLow": 66.05291350252921,
        "expectedHigh": 147.25099524477625,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 156,
        "expectedLow": 59.51662006855617,
        "expectedHigh": 191.2791591785534,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 146,
        "expectedLow": 65.28889685101046,
        "expectedHigh": 213.08418860133892,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 168,
        "expectedLow": 117.88597080399968,
        "expectedHigh": 327.22884619806973,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 165,
        "expectedLow": 83.59210935538711,
        "expectedHigh": 228.72401957233507,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 337,
        "expectedLow": 92.96798231475432,
        "expectedHigh": 241.5741654992306,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 306,
        "expectedLow": 91.21096091768194,
        "expectedHigh": 342.53596861799303,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 245,
        "expectedLow": 88.98297496717365,
        "expectedHigh": 350.2962619618492,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 139,
        "expectedLow": 101.83200044573742,
        "expectedHigh": 401.6572695574827,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 128,
        "expectedLow": 78.67634065847726,
        "expectedHigh": 423.5534467637802,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 102,
        "expectedLow": 34.5269323613206,
        "expectedHigh": 328.03144442185936,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 88,
        "expectedLow": 8.258303069853905,
        "expectedHigh": 337.6409227788584,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "IZI (System, X-Ray, Angiographic) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-2411-2026). 3 first-time filers in the last 12 months, including Stryker Endoscopy and Surgimage Corporation (K261037, K253181, K243645). The code is crowded, scoring 75 of 100 — 84 companies hold a clearance here and 3 arrived in the last 12 months (IZI:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2411-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "3 first-time filers in the last 12 months, including Stryker Endoscopy and Surgimage Corporation",
        "recordIds": [
          "K261037",
          "K253181",
          "K243645"
        ],
        "severity": 43
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 75 of 100 — 84 companies hold a clearance here and 3 arrived in the last 12 months",
        "recordIds": [
          "IZI: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%3AIZI"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AIZI"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AIZI"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AIZI"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AIZI"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AIZI"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AIZI"
    }
  ],
  "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"
}