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510(k) Data Aggregation

    K Number
    K032681
    Device Name
    KONICA LASER IMAGER, MODEL DRYPRO MODEL 771
    Manufacturer
    KONICA MEDICAL AND GRAPHIC CORPORATION
    Date Cleared
    2003-09-24

    (26 days)

    Product Code
    LMC
    Regulation Number
    892.2040
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    KONICA MEDICAL AND GRAPHIC CORPORATION

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

    The Konica Laser Imager DRYPRO model 771 is a laser imager converts data from diagnostic equipment such as CT, MRI, DSA, and other medical devices into various intensities, scan and then print the data onto laser imaging film.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical image hardcopy device, the "Konica Laser Imager DRYPRO model 771." It does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It details regulatory information and contact points but does not describe any performance studies, data provenance, ground truth establishment, or expert involvement.

    Therefore, I cannot fulfill your request for the specific information about acceptance criteria and a detailed study as this information is not present in the provided document.

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