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510(k) Data Aggregation

    K Number
    K090578
    Device Name
    SHIMADZU COLLIMATOR R-30H
    Manufacturer
    SHIMADZU CORP.
    Date Cleared
    2009-11-06

    (248 days)

    Product Code
    IZW
    Regulation Number
    892.1610
    Type
    Abbreviated
    Panel
    Radiology
    Reference & Predicate Devices
    K031771
    Why did this record match?
    Reference Devices :

    K031771

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

    The R-30H is used to take the radiography of patients. The intended for use of the R-30H are also the same as of the predicate beam limiting device R-30H (K031771).

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the R-30H. The document is an FDA 510(k) clearance letter for the R-30H, an angiographic x-ray system. It states that the device is substantially equivalent to a predicate device and can be marketed, but it does not detail any performance studies, acceptance criteria, or specific metrics.

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