BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TrackX

    K Number: K200360 · Decision Mar 5, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    319
    Applicant Total
    2
    Review Days
    21

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    Basic Information

    Device Name
    TrackX
    K Number
    K200360
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Track X Technology, LLC
    Date Received
    February 13, 2020
    Decision Date
    March 5, 2020
    Product Code
    OWB
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OWB Interventional Fluoroscopic X-Ray System

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    Other Clearances by Track X Technology, LLC

    K Number Device Name
    K173736 TrackX