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

    MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM

    K Number: K081859 · Decision Aug 4, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    7
    Review Days
    34

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    Basic Information

    Device Name
    MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM
    K Number
    K081859
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sicel Technologies, Inc.
    Date Received
    July 1, 2008
    Decision Date
    August 4, 2008
    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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    Other Clearances by Sicel Technologies, Inc.

    K Number Device Name
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    K061051 DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER
    K052118 DOSE VERIFICATION SYSTEM
    K040687 ONEDOSE PATIENT DOSIMETRY SYSTEM