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510(k) Data Aggregation

    K Number
    K061560
    Device Name
    SONOMARK
    Manufacturer
    MEDICAL PRODUCTS MANUFACTURING, INC.
    Date Cleared
    2006-08-18

    (74 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K053463
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sonomark® accessory to linear diagnostic ultrasound transducers is indicated for diagnostic ultrasound procedures to mark anatomical features.

    Device Description

    The Sonomark® accessory to Diagnostic Ultrasound Transducers is a skin-marking attachment.

    AI/ML Overview

    The provided text is a 510(k) summary for the Sonomark® accessory. It does not contain information about acceptance criteria, device performance, or any study details that would prove the device meets such criteria.

    The 510(k) summary focuses on establishing substantial equivalence to a predicate device (AiM Accuracy in Marking® System, K053463) and outlines the regulatory classification, intended use, and indications for use. It's a regulatory document for market clearance, not a technical report detailing performance studies.

    Therefore, I cannot fulfill your request for the tables and study details based on the provided input. The document explicitly states: "Substantial equivalence has been demonstrated between the Sonomark® accessory, the AiM Accuracy in Marking® System (510(k) No.: K053463)." This suggests that the device's market clearance relied on proving similarity to an already approved device rather than presenting new performance study data against specific acceptance criteria.

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