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510(k) Data Aggregation

    K Number
    K113708
    Device Name
    ORTHOSCAN MOBILE DI MINI C-ARM
    Manufacturer
    ORTHOSCAN, INC.
    Date Cleared
    2012-01-05

    (20 days)

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

    ORTHOSCAN MOBILE DI MINI C-ARM

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

    The OrthoScan Mobile DI Mini C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures in hospital, emergency care, critical care, or physician office environments.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria or any study that proves the device meets specific acceptance criteria. The document is primarily a letter from the FDA regarding the 510(k) premarket notification for the OrthoScan Mobile DI Mini C-Arm, confirming its substantial equivalence to legally marketed predicate devices and outlining regulatory requirements. It does not contain details of performance studies, sample sizes, ground truth establishment, or expert qualifications.

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