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

    HF 718BD X-Ray System

    K Number: K160857 · Decision Feb 24, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    355
    Applicant Total
    1
    Review Days
    332

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    Basic Information

    Device Name
    HF 718BD X-Ray System
    K Number
    K160857
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arquilla, Inc. Dba X-Cel X-Ray Corporation
    Date Received
    March 29, 2016
    Decision Date
    February 24, 2017
    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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