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510(k) Data Aggregation

    K Number
    K974707
    Device Name
    IMAGEQUEST
    Manufacturer
    VISUAL MED, INC.
    Date Cleared
    1998-07-31

    (227 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISUAL MED, INC.

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

    ImageQUEST is communication system that has a database to allow Imaging Professionals to store and find their images and information. ImageQUEST can create teaching files, professional presentations and E-mail images to other professionals at remote locations and generate reports.

    Device Description

    ImageQUEST is communication system that has a database to allow Imaging Professionals to store and find their images and information. ImageQUEST can create teaching files, professional presentations and E-mail images to other professionals at remote locations and generate reports.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "ImageQUEST - Communications Software." It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    The letter focuses on regulatory approval based on substantial equivalence and general controls, rather than on detailed performance metrics from a specific study.

    Therefore, I cannot fulfill your request for the tables and study details based on the provided text. The document acts as an approval notice, not a performance study report.

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