LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K041763
    Device Name
    SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES
    Manufacturer
    SHIMADZU CORP.
    Date Cleared
    2004-07-13

    (13 days)

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

    SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES

    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.
    The object of this device is total patient populations.
    Exposure can be captured on film, CR or Digital Radiography (DR)

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for the Shimadzu MUX-100D Series mobile x-ray system. It does not contain information about 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. This type of submission (510(k)) focuses on demonstrating that a new device is as safe and effective as an already legally marketed device, rather than on proving its performance against specific acceptance criteria in a detailed clinical study for novel claims.

    Therefore, I cannot extract the requested information from this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1