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510(k) Data Aggregation

    K Number
    K051133
    Device Name
    ARCADIS AVANTIC
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Date Cleared
    2005-06-01

    (29 days)

    Product Code
    OXO,ARC
    Regulation Number
    892.1650
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K040066,K040675
    Why did this record match?
    Reference Devices :

    K040066, K040675

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

    The ARCADIS Avantic is a mobile x-ray system which can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Digital Cine Mode (DCM), Subtraction, and Roadmapping, which are necessary to perform a wide variety of clinical procedures. Clinical applications may include, but are not limited to, card/vascular, gastroenterology, electrophysiology, urologic, orthopedic, neurologic, pediatrics, endoscopy, pain therapy and emergency room procedures

    Device Description

    The ARCADIS Avantic is an x-ray system which consists of a mobile C-arm configured with a high frequency generator, X-ray tube assembly, image intensifier, TV camera, laser target devices, electronics cabinet, a monitor trolley and digital image storage system which consists of the digital memory device, image monitor(s), and user interface. The system is equipped with a footswitch and a hand switch for radiation release.

    AI/ML Overview

    The provided text is a 510(k) summary for a mobile X-ray system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on the results of a detailed performance study against specific acceptance criteria.

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