BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇽 Mexico

    MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System

    K Number: K193637 · Decision Jan 28, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    347
    Applicant Total
    2
    Review Days
    32

    Basic Information

    Device Name
    MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System
    K Number
    K193637
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Compania Mexicana De Radiologia CGR, S.A. DE C.V.
    Date Received
    December 27, 2019
    Decision Date
    January 28, 2020
    Product Code
    KPR
    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
    KPR System, X-Ray, Stationary

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    Other Clearances by Compania Mexicana De Radiologia CGR, S.A. DE C.V.

    K Number Device Name
    K182134 ARiX RAD Radiographic System