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510(k) Data Aggregation

    K Number
    K013426
    Device Name
    MOONRAY MOBILE C-ARM
    Manufacturer
    SIMAD S.R.L.
    Date Cleared
    2002-03-26

    (161 days)

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

    MOONRAY MOBILE C-ARM

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

    The Pathfinder Mobile C-Arm is intended to be used for routine radiography and follow-up x-rays after studies such as (e.g. gastrointestinal studies, chest, bone, hip panings, and pacemaker implants).

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the MOONRAY Mobil C-Arm, indicating that the device has been found substantially equivalent to a legally marketed predicate device. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The letter only confirms the regulatory clearance of the device.

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