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510(k) Data Aggregation

    K Number
    K984156
    Device Name
    SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Date Cleared
    1999-04-21

    (153 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K955255
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended to be used in the examination of the whole body. / This device is used optionally in CT Fluoroscopy. / This device is operated and used by Physicians and X-ray technologist. / The object of this device is total patient populations. As mentioned at "Intended Use" in this clearance letter, the intended use of the SCT-7000TX W/FLUORO OPTION is the same as that of predicate device SCT-7000TX (K955255) except optional CT fluoroscopy . Consequently, the indications for use of the SCT-7000TX W/FLUORO OPTION are also the same as that of the SCT-7000TX (K955255) except optional CT fluoroscopy

    Device Description

    SCT-7000TX X-ray CT Scanner with Fluoro Option

    AI/ML Overview

    The provided documents are correspondence from the FDA regarding a 510(k) clearance for the Shimadzu SCT-7000TX X-ray CT Scanner with Fluoro Option (K984156), and an "Indications For Use" statement.

    These documents do not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. They are administrative documents related to regulatory clearance based on substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested information.

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