BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    THERAPY CHAIR SYSTEM

    K Number: K910648 · Decision Jul 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    31
    Applicant Total
    7
    Review Days
    158

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    THERAPY CHAIR SYSTEM
    K Number
    K910648
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5770
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Radiation Technology, Inc.
    Date Received
    February 14, 1991
    Decision Date
    July 22, 1991
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JAI), ordered by most recent decision date.

    Eve Patient Positioner System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Z-Robot Patient Positioning System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Patient Positioning System

    FDA 510(k)
    FDA Class 2 ·Radiology

    LEONI ORION System

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROTURA COUCH SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    PATIENT POSITIONING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    Other Clearances by Radiation Technology, Inc.

    K Number Device Name
    K802892 CULTURE MEDIA FOR IN VITRO DIAG. USE
    K801943 BRAIN HEART INFUSION MICROBIOLOGICAL
    K801817 MICROBIOLOGY CULTURE MEDIA, C.L.E.D.
    K801772 MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG
    K801901 MUELLER HINTON AGAR
    K801847 TRIPLE SUGAR IRON AGAR(MICRO/CULT/MEDIA