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510(k) Data Aggregation

    K Number
    K964414
    Device Name
    LR 5200 LASER FILM RECORDER
    Manufacturer
    BAYER CORP., AGFA DIV.
    Date Cleared
    1997-01-27

    (83 days)

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

    LR 5200 LASER FILM RECORDER

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

    The diseases and conditions that the device will aid in the diagnosis of, are those that are typical to radiological types of examinations.

    Device Description

    The LR 5200 is a laser based (Helium-neon) film recorder, designed for producing high quality gray scale diagnostic medical images, when interfaced to a host imaging device. Typical host imaging devices would include those of Magnetic Resonance, Computed Tomography, Ultrasound, Mammography, Digital Radiography, and Nuclear Medicine imaging modalities.

    AI/ML Overview

    There is insufficient information in the provided text to describe acceptance criteria and associated study details. The document is a 510(k) summary for a "Laser Film Recorder" and focuses on device description, technological characteristics, and substantial equivalence to other devices. It does not contain any details about acceptance criteria for performance metrics, clinical studies, or AI/algorithm performance.

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