LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K012010
    Device Name
    MODIFICATION TO LR 5200 FILM RECORDER
    Manufacturer
    AGFA CORP.
    Date Cleared
    2001-09-20

    (85 days)

    Product Code
    LMC
    Regulation Number
    892.2040
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K964414
    Why did this record match?
    Device Name :

    MODIFICATION TO LR 5200 FILM RECORDER

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

    The LR5200 Laser Film Recorder is indicated for use in providing diagnostic quality medical images on film for aid in physician diagnosis, including the printing of images from various digital imaging source modalities, including, but not limited to, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Ultrasound, Computed Radiography, Digital Mammography, and Nuclear Medicine.

    Device Description

    No changes in hardware or software are being implemented to the currently marketed LR5200. The present 510(k) is only for a clarification in the indications for use. The LR5200 is a laser (He-Ne) film recorder designed to produce high quality gray scale diagnostic medical images when interfacted to a host imaging device or PACS system. The LR5200 uses a wet process for developing the medical images.

    AI/ML Overview

    The provided text is a 510(k) summary for the Agfa LR 5200 Laser Film Recorder. Upon review, it's clear that this submission is not for a new device requiring performance testing against acceptance criteria. Instead, it's a clarification of the indications for use for an already legally marketed device (K964414).

    Therefore, no acceptance criteria or study data demonstrating device performance are provided in this document. The key statements confirming this are:

    • "No changes in hardware or software are being implemented to the currently marketed LR5200."
    • "The present 510(k) is only for a clarification in the indications for use."
    • "No additional testing was carried out for this premarket notification since the device is already indicated for the same uses."
    • "The LR 5200 Laser Film Recorder has the same (identical) technological characteristics as the predicate device."

    Because this submission is an amendment regarding indications for use and explicitly states "No additional testing was carried out," the request for details on acceptance criteria, device performance, sample sizes, experts, adjudication, MRMC studies, standalone performance, and ground truth for testing and training cannot be fulfilled from this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1