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

    Patient Positioning System

    K Number: K170502 · Decision Apr 13, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    31
    Applicant Total
    2
    Review Days
    51

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    Basic Information

    Device Name
    Patient Positioning System
    K Number
    K170502
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5770
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Forte Automation Systems, Inc.
    Date Received
    February 21, 2017
    Decision Date
    April 13, 2017
    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
    K122413 PATIENT POSITIONING SYSTEM