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

    PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100

    K Number: K034054 · Decision Feb 20, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    31
    Applicant Total
    8
    Review Days
    52

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    Basic Information

    Device Name
    PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100
    K Number
    K034054
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5770
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Med-Tec,Inc.
    Date Received
    December 30, 2003
    Decision Date
    February 20, 2004
    Product Code
    JAI
    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
    JAI Couch, Radiation Therapy, Powered

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