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510(k) Data Aggregation

    K Number
    K214030
    Device Name
    Universal DR 1748
    Manufacturer
    Konica Minolta Healthcare Americas, Inc.
    Date Cleared
    2022-01-21

    (29 days)

    Product Code
    MQB,IZL,LLZ
    Regulation Number
    892.1680
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K212291,K210919
    Why did this record match?
    Device Name :

    Universal DR 1748

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

    This device is indicated for use in generating radiographic images of human anatomy. It is intended to a replace radiographic film/screen system in general-purpose diagnostic procedures. This device is not indicated for use in mammography, fluoroscopy, and angiography applications.

    Device Description

    Konica Minolta Universal DR 1748 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panel.

    AI/ML Overview

    This document describes the regulatory submission for the Universal DR 1748, an upgrade kit for digital X-ray systems. It asserts substantial equivalence to a predicate device, the Konica Minolta SKR 3000 (K210619). The primary difference is the digital X-ray panel and associated software.

    However, the provided text does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 regarding acceptance criteria and the detailed study that proves the device meets those criteria for the AI/Software component (Ultra software).

    The mention of the "Ultra" software suggests it is a crucial component of the new system, having been previously cleared (K212291). The relevant part states: "The digital panel software employed was used unmodified from clearance obtained from FDA. The software has been validated as a control for CPI and Sedecal diagnostic x-ray generators."

    This means that the software's performance and validation were established in its prior clearance (K212291) and are not re-evaluated in detail within this specific K214030 submission summary. The current submission focuses on the integration of this pre-cleared software with new hardware components (the Venu1748V digital panel).

    Therefore, based solely on the provided text, I cannot extract the specific details about the acceptance criteria and the study proving the software's performance. The document only confirms that the software was "unmodified" from a previously cleared version and "validated as a control" for certain generators.

    To provide the requested information, one would need to access the K212291 submission for the "Ultra" software, as that is where its performance studies would have been detailed.

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