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

    RAD. THERAPY PLANNING SUP. SYS.

    K Number: K772305 · Decision Jan 9, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    7
    Review Days
    26

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    Basic Information

    Device Name
    RAD. THERAPY PLANNING SUP. SYS.
    K Number
    K772305
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Ohio Nuclear, Inc.
    Date Received
    December 14, 1977
    Decision Date
    January 9, 1978
    Product Code
    JAK
    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
    JAK System, X-Ray, Tomography, Computed

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