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510(k) Data Aggregation

    K Number
    K071140
    Device Name
    MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002
    Manufacturer
    TOPSPINS, INC.
    Date Cleared
    2007-06-07

    (44 days)

    Product Code
    KCY
    Regulation Number
    878.5910
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002

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

    This device is intended for use in MR imaging of peripheral blood yessels in the lower extremity for patients with suspected peripheral vascular disease for diagnostic purposes and pre-operative information.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

    The letter states that the device, an "MRI Compatible Thigh Tourniquet," has been determined to be substantially equivalent to legally marketed predicate devices. This determination is based on the indications for use provided by the applicant.

    Therefore, I cannot extract the requested information as it is not present in the provided document.

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