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510(k) Data Aggregation

    K Number
    K993742
    Device Name
    SUPER TISSUE
    Manufacturer
    I.Z.I. CORP.
    Date Cleared
    2000-02-02

    (90 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SUPER TISSUE

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

    For use in high energy radiation therapy to correct for anatomical irregularities and deliver the prescribed dose to the skin surface and underlying tissue.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the text provided, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a device called "Super Tissue". It confirms that the device is substantially equivalent to a predicate device and can be marketed. However, it does not contain any information about acceptance criteria, study details, performance data, sample sizes, expert ground truth, or any of the other specific study-related information you requested.

    The document is purely a regulatory clearance and does not include the technical study results that would typically accompany such a submission.

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