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510(k) Data Aggregation

    K Number
    K101350
    Device Name
    RADSCAN EQUIPMENT SLICKER
    Manufacturer
    RADSCAN MEDICAL EQUIPMENT, INC.
    Date Cleared
    2011-01-04

    (235 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADSCAN MEDICAL EQUIPMENT, INC.

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

    This single use sterile equipment cover is intended for use by professionals in a sterile clinical setting to cover and prevent contamination of non-patient contact equipment during various procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the "RadScan Equipment Slicker®". This type of document determines substantial equivalence to a predicate device and approves the device for market. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews as requested in your prompt. These details would typically be found in the manufacturer's submission to the FDA, which is not included here.

    Therefore, I cannot provide the requested information based on the given document.

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