{
  "companyId": "63949",
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  "name": "Hitachi Medical Systems America Inc",
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    "last12Months": 0,
    "first": "1991-05-30",
    "latest": "2017-03-03"
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  "productCodeCount": 13,
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    "total": 45,
    "openLast12Months": 0,
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      {
        "resNumber": "Z-1282-2021",
        "productCode": "IYN",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2021-03-01",
        "reason": "Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the focus point and transducer aperture settings in the SWE function. When the affected software with SWE function is used in conjunction with the C252 probe, this error can result in out of specification MI/TI acoustic output. The MI/TI acoustic output is higher than regulatory limits."
      },
      {
        "resNumber": "Z-1341-2020",
        "productCode": "ITX",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2020-01-31",
        "reason": "These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings."
      },
      {
        "resNumber": "Z-0271-2020",
        "productCode": "JAK",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2019-10-16",
        "reason": "There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system."
      },
      {
        "resNumber": "Z-2839-2018",
        "productCode": "JAK",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2018-06-29",
        "reason": "The firm received a complaint where, during patient positioning, the technologist was adjusting the patient table height and the table failed to stop when the control was released and contacted the CT gantry. The problem could not be duplicated at the site, so to avoid further issues while a root cause investigation was pursued, Hitachi choose to add an optional touch sensor to the gantry to add a redundant level of protection. It is conceivable that a patient s extremity may be caught between the tabletop and the gantry surface during uncontrolled motion or that the table contact of the gantry might cause internal damage to the unit."
      },
      {
        "resNumber": "Z-2479-2018",
        "productCode": "LNH",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2018-06-18",
        "reason": "The stainless steel belt which runs the length of the table underneath the tabletop is exposed when the tabletop is extended into the magnet for scanning. The firm has received two complaints where technologists have cut their fingers on this belt."
      }
    ]
  },
  "registration": {
    "sites": 0,
    "countries": []
  },
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      "code": "LNH",
      "deviceName": "System, Nuclear Magnetic Resonance Imaging",
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      "latest": "2016-05-20",
      "medianReviewDays": 91
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      "code": "MOS",
      "deviceName": "Coil, Magnetic Resonance, Specialty",
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      "latest": "2016-09-16",
      "medianReviewDays": 50
    },
    {
      "code": "JAK",
      "deviceName": "System, X-Ray, Tomography, Computed",
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      "latest": "2017-03-03",
      "medianReviewDays": 86
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      "code": "IYN",
      "deviceName": "System, Imaging, Pulsed Doppler, Ultrasonic",
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      "latest": "2011-09-27",
      "medianReviewDays": 30
    },
    {
      "code": "IYO",
      "deviceName": "System, Imaging, Pulsed Echo, Ultrasonic",
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      "latest": "2010-06-17",
      "medianReviewDays": 115
    },
    {
      "code": "LNI",
      "deviceName": "System, Nuclear Magnetic Resonance Spectroscopic",
      "clearances": 2,
      "latest": "2010-03-16",
      "medianReviewDays": 27
    },
    {
      "code": "DQA",
      "deviceName": "Oximeter",
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      "latest": "2001-08-09",
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      "code": "IZI",
      "deviceName": "System, X-Ray, Angiographic",
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      "latest": "1999-05-24",
      "medianReviewDays": 42
    },
    {
      "code": "IZL",
      "deviceName": "System, X-Ray, Mobile",
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      "latest": "2015-03-06",
      "medianReviewDays": 81
    },
    {
      "code": "JAA",
      "deviceName": "System, X-Ray, Fluoroscopic, Image-Intensified",
      "clearances": 1,
      "latest": "1997-02-26",
      "medianReviewDays": 72
    },
    {
      "code": "KPS",
      "deviceName": "System, Tomography, Computed, Emission",
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      "latest": "2004-09-17",
      "medianReviewDays": 9
    },
    {
      "code": "LLZ",
      "deviceName": "System, Image Processing, Radiological",
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      "latest": "2002-07-02",
      "medianReviewDays": 68
    },
    {
      "code": "MUH",
      "deviceName": "System, X-Ray, Extraoral Source, Digital",
      "clearances": 1,
      "latest": "2003-10-20",
      "medianReviewDays": 13
    }
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  "productCodesTotal": "13",
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      "kNumber": "K163528",
      "deviceName": "HITACHI Supria Whole-body X-ray CT System Phase 3",
      "productCode": "JAK",
      "decisionDate": "2017-03-03",
      "reviewDays": 77
    },
    {
      "kNumber": "K162079",
      "deviceName": "TRILLIUM Oval Head Coil 32",
      "productCode": "MOS",
      "decisionDate": "2016-09-16",
      "reviewDays": 51
    },
    {
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      "deviceName": "SUPRIA w/guideShot Option",
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      "kNumber": "K160152",
      "deviceName": "Trillium Oval V 5.1 MRI System",
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      "decisionDate": "2016-05-20",
      "reviewDays": 119
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    {
      "kNumber": "K153547",
      "deviceName": "ECHELON Oval V 5.1 MRI System",
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    {
      "kNumber": "K150595",
      "deviceName": "SCENARIA Phase 3 Whole-body X-ray CT System",
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    {
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    {
      "kNumber": "K151015",
      "deviceName": "ECHELON Oval V 5.0 MRI System",
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    },
    {
      "kNumber": "K143537",
      "deviceName": "Sirius Starmobile tiara",
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    },
    {
      "kNumber": "K142734",
      "deviceName": "TRILLIUM Oval MR System",
      "productCode": "LNH",
      "decisionDate": "2015-03-02",
      "reviewDays": 160
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    "shown": [
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        "name": "Hitachi Medical Systems America Inc",
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        "method": "normalised"
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        "name": "Hitachi Medical Systems America, Inc.",
        "dataset": "device/510k",
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      }
    ]
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    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Hitachi%20Medical%20Systems%20America%20Inc%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Hitachi%20Medical%20Systems%20America%20Inc%22"
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  "retrievedAt": "2026-08-11T14:48:53.045Z"
}