BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    THERAC 25 LINEAR ACCELERATOR

    K Number: K837152 · Decision Mar 22, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    31
    Applicant Total
    6
    Review Days
    387

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    Basic Information

    Device Name
    THERAC 25 LINEAR ACCELERATOR
    K Number
    K837152
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5770
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Atomic Energy of Canada
    Date Received
    February 28, 1982
    Decision Date
    March 22, 1983
    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 Atomic Energy of Canada

    K Number Device Name
    K850543 THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY
    K837347 LINEAR ACCELERATOR THERAC 25
    K837346 MODEL GAMMACELL 1000
    K771260 LINEAR ACCELERATOR G-2900
    K771096 TELHTHERAPY SIMULATOR AECL-CP, G-3200