{
  "companyId": "52472",
  "slug": "varian-medical-systems-inc-52472",
  "name": "Varian Medical Systems, Inc.",
  "clearances": {
    "total": 205,
    "last12Months": 10,
    "first": "1997-01-10",
    "latest": "2026-07-10"
  },
  "medianReviewDays": 83,
  "productCodeCount": 15,
  "recalls": {
    "total": 63,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-1899-2020",
        "productCode": "IYE",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2019-08-12",
        "reason": "After a recent upgrade to the collimator software version 8.5, the firm became aware that the multi-leaf collimator leaves did not move during an arc treatment. The issue is related to a transient carriage primary- secondary interlock due to carriage fault on the MLC that immediately preceded the initiation of the arc treatment. The issue will occur only with MLC software version 8.5 and only affects conformal arc treatments, including VMAT and RapidArc. There have been no reports of adverse health consequences due to this issue."
      },
      {
        "resNumber": "Z-0771-2019",
        "productCode": "MUJ",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2018-12-26",
        "reason": "There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm.  The PCS algo- rithm calculates the water equivalent range incorrectly for non-square 3D CT images (either different number of pixels in X and Y, or non-square pixels).  Before the dose is calculated, Eclipse resamples the CT images to create a calculation image with a maximum resolution of 256 x 256. The PCS algorithm assumes uniform resolution in X and Y directions, or that X = Y for all images, and erroneously sets the Y = X for dose calcu- lation.  For images that are not square, where either X<>Y, or the length of X does not equal the length of Y, the computed water equivalent range R  is erroneous compared to the correct range R: 1) X=Y; R =R (R  is correct); 2) XY  R >R (R  is too big)."
      },
      {
        "resNumber": "Z-0004-2019",
        "productCode": "IYE",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2018-08-20",
        "reason": "Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system."
      },
      {
        "resNumber": "Z-0005-2019",
        "productCode": "IYE",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2018-08-20",
        "reason": "Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system."
      },
      {
        "resNumber": "Z-0990-2017",
        "productCode": "IYE",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2016-12-02",
        "reason": "Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces resulted in contours not being saved consistently in Eclipse. Treatment Planning System. The issue only occurs if certain conditions are fulfilled."
      }
    ]
  },
  "registration": {
    "sites": 5,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "IYE",
      "deviceName": "Accelerator, Linear, Medical",
      "clearances": 82,
      "latest": "2026-01-21",
      "medianReviewDays": 60
    },
    {
      "code": "JAQ",
      "deviceName": "System, Applicator, Radionuclide, Remote-Controlled",
      "clearances": 59,
      "latest": "2026-05-20",
      "medianReviewDays": 109
    },
    {
      "code": "MUJ",
      "deviceName": "System, Planning, Radiation Therapy Treatment",
      "clearances": 33,
      "latest": "2026-07-08",
      "medianReviewDays": 73
    },
    {
      "code": "LHN",
      "deviceName": "System, Radiation Therapy, Charged-Particle, Medical",
      "clearances": 8,
      "latest": "2026-04-23",
      "medianReviewDays": 85
    },
    {
      "code": "JAK",
      "deviceName": "System, X-Ray, Tomography, Computed",
      "clearances": 4,
      "latest": "2026-06-04",
      "medianReviewDays": 59
    },
    {
      "code": "KPQ",
      "deviceName": "System, Simulation, Radiation Therapy",
      "clearances": 4,
      "latest": "2003-12-30",
      "medianReviewDays": 74
    },
    {
      "code": "GEH",
      "deviceName": "Unit, Cryosurgical, Accessories",
      "clearances": 3,
      "latest": "2023-03-28",
      "medianReviewDays": 60
    },
    {
      "code": "KXK",
      "deviceName": "Source, Brachytherapy, Radionuclide",
      "clearances": 3,
      "latest": "2015-05-08",
      "medianReviewDays": 58
    },
    {
      "code": "KRD",
      "deviceName": "Device, Vascular, For Promoting Embolization",
      "clearances": 2,
      "latest": "2025-01-17",
      "medianReviewDays": 30
    },
    {
      "code": "NEY",
      "deviceName": "System, Ablation, Microwave And Accessories",
      "clearances": 2,
      "latest": "2024-07-19",
      "medianReviewDays": 69
    },
    {
      "code": "KPR",
      "deviceName": "System, X-Ray, Stationary",
      "clearances": 1,
      "latest": "1998-06-12",
      "medianReviewDays": 81
    },
    {
      "code": "LLZ",
      "deviceName": "System, Image Processing, Radiological",
      "clearances": 1,
      "latest": "2018-02-15",
      "medianReviewDays": 83
    },
    {
      "code": "LNH",
      "deviceName": "System, Nuclear Magnetic Resonance Imaging",
      "clearances": 1,
      "latest": "2003-06-24",
      "medianReviewDays": 88
    },
    {
      "code": "MQB",
      "deviceName": "Solid State X-Ray Imager (Flat Panel/Digital Imager)",
      "clearances": 1,
      "latest": "2003-02-12",
      "medianReviewDays": 58
    },
    {
      "code": "QKB",
      "deviceName": "Radiological Image Processing Software For Radiation Therapy",
      "clearances": 1,
      "latest": "2026-07-10",
      "medianReviewDays": 81
    }
  ],
  "productCodesShown": 15,
  "productCodesTotal": "15",
  "recentClearances": [
    {
      "kNumber": "K261306",
      "deviceName": "AI Contouring (VA10A)",
      "productCode": "QKB",
      "decisionDate": "2026-07-10",
      "reviewDays": 81
    },
    {
      "kNumber": "K260750",
      "deviceName": "Virtual Cone (1.0)",
      "productCode": "MUJ",
      "decisionDate": "2026-07-08",
      "reviewDays": 124
    },
    {
      "kNumber": "K253026",
      "deviceName": "Respiratory Gating for Scanners (2.1)",
      "productCode": "JAK",
      "decisionDate": "2026-06-04",
      "reviewDays": 258
    },
    {
      "kNumber": "K252717",
      "deviceName": "MAASTRO Rectal Applicator Set",
      "productCode": "JAQ",
      "decisionDate": "2026-05-20",
      "reviewDays": 265
    },
    {
      "kNumber": "K252815",
      "deviceName": "ProBeam 360 Proton Therapy System v3.0",
      "productCode": "LHN",
      "decisionDate": "2026-04-23",
      "reviewDays": 231
    },
    {
      "kNumber": "K252304",
      "deviceName": "syngo.via RT Image Suite VC10",
      "productCode": "MUJ",
      "decisionDate": "2026-03-18",
      "reviewDays": 237
    },
    {
      "kNumber": "K252977",
      "deviceName": "Halcyon, Ethos Radiotherapy System (5.0)",
      "productCode": "IYE",
      "decisionDate": "2026-01-21",
      "reviewDays": 126
    },
    {
      "kNumber": "K252919",
      "deviceName": "IDENTIFY (5.0)",
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      "decisionDate": "2025-12-16",
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    },
    {
      "kNumber": "K252884",
      "deviceName": "Guided Aarhus Applicator Set",
      "productCode": "JAQ",
      "decisionDate": "2025-11-19",
      "reviewDays": 70
    },
    {
      "kNumber": "K252948",
      "deviceName": "TrueBeam, TrueBeam STX, Edge and VitalBeam",
      "productCode": "IYE",
      "decisionDate": "2025-10-07",
      "reviewDays": 21
    }
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    "shown": [
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        "name": "Varian Medical Systems",
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        "method": "normalised"
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      {
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      {
        "name": "Varian Medical Systems Inc",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Varian Medical Systems Inc.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Varian Medical Systems, Inc",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Varian Medical Systems, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Varian%20Medical%20Systems%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Varian%20Medical%20Systems%2C%20Inc.%22"
  },
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2
    },
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      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53
    },
    {
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    {
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      "loadedAt": "2026-08-10T07:06:24Z",
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  ],
  "retrievedAt": "2026-08-11T14:48:53.029Z"
}