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

    ONEDOSE PATIENT DOSIMETRY SYSTEM

    K Number: K040687 · Decision Jun 25, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    7
    Review Days
    101

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    Basic Information

    Device Name
    ONEDOSE PATIENT DOSIMETRY SYSTEM
    K Number
    K040687
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sicel Technologies, Inc.
    Date Received
    March 16, 2004
    Decision Date
    June 25, 2004
    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.

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    K083035 DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
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    K080004 DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
    K071399 DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100
    K061051 DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER
    K052118 DOSE VERIFICATION SYSTEM