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510(k) Data Aggregation

    K Number
    K060451
    Device Name
    M-VU VIEWER STATION
    Manufacturer
    VUCOMP, INC.
    Date Cleared
    2006-03-22

    (29 days)

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

    M-VU VIEWER STATION

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

    The M-Vu™ Viewer Station is intended to be used to display low resolution, non-diagnostic, medical images with annotations such as pre-computed regions-of-interest or pre-computed CAD marks.

    Device Description

    The M-Vu™ Viewer Station is a computer-based system that displays digitized. low-resolution, radiographic information. The system is typically used to support a radiologist's review of screening and/or diagnostic mammograms. The system has two main functional components: a commercially available computer with an integrated LCD display and an attached bar code reader. The computer is connected to the M-Vu™ CAD Station via an Ethernet network to download selected radiographic images and Computer-Aided Detection (CAD) results or other annotations. The Viewer Station serves no other purpose than providing convenient viewer support.

    AI/ML Overview

    The provided 510(k) summary for the M-Vu™ Viewer Station explicitly states:

    "8. Discussion of Clinical Tests Performed: Not applicable"

    This means that a clinical study was not performed to prove the device meets specific acceptance criteria based on human performance or diagnostic accuracy. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on non-clinical tests (software validation and verification testing) and similar intended use and characteristics.

    Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for clinical studies cannot be extracted from this document because such studies were not conducted for this submission.

    The document indicates that the device's safety and effectiveness were supported by:

    • Non-Clinical Tests: Software validation and verification testing.
    • Comparison to Predicate Device: The M-Vu™ Viewer Station was found substantially equivalent to the Second Look® Viewer (K#042697) based on intended use and technological characteristics, with differences (e.g., mouse vs. touch screen, printing options) not raising new questions of safety or effectiveness.
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