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

    PATIENT POSITIONING SYSTEM

    K Number: K122413 · Decision Sep 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    31
    Applicant Total
    2
    Review Days
    36

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    Basic Information

    Device Name
    PATIENT POSITIONING SYSTEM
    K Number
    K122413
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5770
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Forte Automation Systems, Inc.
    Date Received
    August 8, 2012
    Decision Date
    September 13, 2012
    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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    Other Clearances by Forte Automation Systems, Inc.

    K Number Device Name
    K170502 Patient Positioning System