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510(k) Data Aggregation

    K Number
    K080701
    Device Name
    SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION
    Manufacturer
    SHIMADZU CORP.
    Date Cleared
    2008-05-14

    (64 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Type
    Abbreviated
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION

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

    This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)

    Device Description

    Mobile x-ray system

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Shimadzu Medical Systems regarding their MobileDaRt Evolution device. This document confirms the substantial equivalence of the device to legally marketed predicate devices.

    However, the text does not contain any information about acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, or ground truth establishment. The letter is purely an administrative communication confirming market clearance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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