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510(k) Data Aggregation

    K Number
    K032022
    Device Name
    DIGITAL IMAGER
    Manufacturer
    PYRAMID MEDICAL, INC.
    Date Cleared
    2003-09-02

    (64 days)

    Product Code
    LMA
    Regulation Number
    892.2030
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PYRAMID MEDICAL, INC.

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

    The Digital Imager software is used to acquire and store image or patient data. This data can then be transmitted, stored and viewed over a computer network or off-site using an internet connection. Typical users of this system are trained professionals, including but not limited to physicians, technicians and nurses.

    Device Description

    Digital Imager software is used to acquire and store image or patient data. This data can then be transmitted, stored and viewed over a computer network or off-site using an internet connection.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Pyramid Medical, Inc. regarding their "Digital Imager" device. It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information regarding acceptance criteria, study details, device performance, sample sizes, ground truth establishment, or expert qualifications. The letter is an approval notification, not a technical report or scientific study summary.

    Therefore, I cannot answer the questions based on the provided input.

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