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510(k) Data Aggregation

    K Number
    K201058
    Device Name
    Accuvue+
    Manufacturer
    Radmedix LLC
    Date Cleared
    2020-05-06

    (15 days)

    Product Code
    MQB,IZL,LLZ,MOB
    Regulation Number
    892.1680
    Type
    Special
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K192400,K193017,K171137,K162552,K162555,K200726
    Why did this record match?
    Device Name :

    Accuvue+

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

    Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

    Device Description

    Accuvue+ components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one (or more) of the following digital x-ray receptor panels: DRTech 4343A, (K192400); DRTech 4343W, (K193017); AcuityDR (K171137); AcuityDR 1417 (K162552 EVS 3643G) or AcuityDR 1717 (K162555 EVS 4343, EVS 4343G). We wish to offer for sale a subset of our recently cleared submission K200726. This in essence would be an upgrade kit. The indications for use remains unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the generator/tubestand combination.

    AI/ML Overview

    This document is a 510(k) summary for a medical device called Accuvue+. It describes the device and its intended use, and argues for its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through a clinical or non-clinical study.

    The document explicitly states:

    • "6. Clinical testing. Not required for a determination of substantial equivalence."
    • "5. Non clinical testing: Testing was performed in previous submssions according to the following standards:" (It then lists general safety and communication standards, not performance criteria for diagnostic accuracy or image quality.)

    Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria from the provided text. The submission focuses on demonstrating substantial equivalence based on technological characteristics and adherence to general safety standards, rather than a performance study with acceptance criteria.

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