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

    PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90

    K Number: K092285 · Decision Aug 28, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    1
    Review Days
    30

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    Basic Information

    Device Name
    PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90
    K Number
    K092285
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Best Medical Canada , Ltd.
    Date Received
    July 29, 2009
    Decision Date
    August 28, 2009
    Product Code
    IYE
    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
    IYE Accelerator, Linear, Medical

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