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510(k) Data Aggregation

    K Number
    K043379
    Device Name
    SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200
    Manufacturer
    SHIMADZU CORP.
    Date Cleared
    2005-02-17

    (71 days)

    Product Code
    OXO
    Regulation Number
    892.1650
    Type
    Abbreviated
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • The device is a Surgical Mobile C-arm Imaging X-ray System and allows a technician to examine a patient by fluoroscopy or radiography.
    • This device is operated and used by Physicians and X-ray technologist.
    • The object of this device is total patient populations.
    Device Description

    The device is a Surgical Mobile C-arm Imaging X-ray System.

    AI/ML Overview

    This is a 510(k) premarket notification for a Shimadzu Corporation Surgical Mobile C-arm Imaging X-ray System, model WHA-200. This document is an FDA communication regarding substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information from the provided text.

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