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510(k) Data Aggregation

    K Number
    K982583
    Device Name
    SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL
    Manufacturer
    SHIMADZU CORP.
    Date Cleared
    1998-10-05

    (73 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 X-ray CT scanning on whole body.
    · This device is operated and used by Physicians and X-ray technologist.
    · The object of this device is total patient population.
    As mentioned at " Intended Use " in this clearance letter, the intended use of the SCT-6800TXL is as same as that of predicate device SCT- 7000TX ( K955255) and there is no additional indication.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification letter from the FDA regarding an X-ray CT scanner. This document does not describe acceptance criteria or a study proving that a device meets acceptance criteria. It is a regulatory approval document confirming substantial equivalence to a predicate device.

    Therefore, I cannot extract the requested information from the provided text.

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