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

    TCT-1 TREATMENT COUCH

    K Number: K834201 · Decision Mar 5, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    31
    Applicant Total
    2
    Review Days
    91

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    Basic Information

    Device Name
    TCT-1 TREATMENT COUCH
    K Number
    K834201
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5770
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Therados, Inc.
    Date Received
    December 5, 1983
    Decision Date
    March 5, 1984
    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 Therados, Inc.

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