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

    DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM

    K Number: K080004 · Decision Jan 23, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    7
    Review Days
    21

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    Basic Information

    Device Name
    DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
    K Number
    K080004
    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
    January 2, 2008
    Decision Date
    January 23, 2008
    Product Code
    NZT
    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
    NZT Dosimeter, Ionizing Radiation, Implanted

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    Other Clearances by Sicel Technologies, Inc.

    K Number Device Name
    K083035 DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
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    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
    K040687 ONEDOSE PATIENT DOSIMETRY SYSTEM