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    K Number
    K973148
    Device Name
    MACOM
    Manufacturer
    A. STEIN - REGULATORY AFFAIRS CONSULTING
    Date Cleared
    1997-11-20

    (90 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MACOM

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

    MACOM ™ performs real-time digital image enhancement of screen/film mammograms.

    Device Description

    MACOM™ Image Processing System

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the MACOM™ Image Processing System and its Indications for Use statement. It does not contain any information about acceptance criteria, study design, or performance metrics.

    Therefore, I cannot answer your request based on the provided input. To describe the acceptance criteria and the study that proves the device meets them, you would need documentation such as a clinical study report, a validation report, or the 510(k) summary which often includes performance data.

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