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510(k) Data Aggregation

    K Number
    K955893
    Device Name
    EVERYTIME TRANSFUCER COVER
    Manufacturer
    AMEDIC AB
    Date Cleared
    1997-12-30

    (746 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    EVERYTIME™ Transducer Cover

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "EVERYTIMETM Transducer Cover." This letter explicitly states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

    However, the letter does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, expert qualifications, or any of the detailed information requested in your prompt.

    Therefore, I cannot provide a response with the requested information based solely on this document. This letter is an administrative clearance, not a technical study report.

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