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

    Fiducial Marker

    K Number: K211590 · Decision Jun 10, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    17
    Review Days
    17

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    Basic Information

    Device Name
    Fiducial Marker
    K Number
    K211590
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carbon Medical Technologies, Inc.
    Date Received
    May 24, 2021
    Decision Date
    June 10, 2021
    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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