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

    CRS RADIATION BEAM SCANNER

    K Number: K914821 · Decision Dec 17, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    419

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    Basic Information

    Device Name
    CRS RADIATION BEAM SCANNER
    K Number
    K914821
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Consolidated Radiation Services, Inc.
    Date Received
    October 25, 1991
    Decision Date
    December 17, 1992
    Product Code
    IYI
    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
    IYI Collimator, Orthovoltage, Therapeutic X-Ray

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