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

    CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System

    K Number: K171755 · Decision Feb 9, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    300
    Applicant Total
    6
    Review Days
    241

    Basic Information

    Device Name
    CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System
    K Number
    K171755
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Omega Medical Imaging, LLC
    Date Received
    June 13, 2017
    Decision Date
    February 9, 2018
    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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