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510(k) Data Aggregation

    K Number
    K032443
    Device Name
    DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE
    Manufacturer
    SHIMADZU CORP.
    Date Cleared
    2004-02-20

    (196 days)

    Product Code
    IZI
    Regulation Number
    892.1600
    Type
    Abbreviated
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended to be used in the Angiography in Hospital with the X-ray devices.
    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 DAR-5000 is the same as that of predicate device DAR-2400-15B/30B (K955395).
    Consequently, the indications for use of the DAR-5000 are also the same as that of the DAR-2400-15B/30B (K955395), and there are no additional indications.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Shimadzu Medical Systems DAR-5000 angiographic x-ray system. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details (sample size, data provenance, expert numbers/qualifications, adjudication), MRMC studies, standalone performance, ground truth types, or training set details based on the provided text.

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