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

    FlexiMarc Marker

    K Number: K142294 · Decision Mar 26, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    3
    Review Days
    220

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    Basic Information

    Device Name
    FlexiMarc Marker
    K Number
    K142294
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cortex Manufacturing, Inc.
    Date Received
    August 18, 2014
    Decision Date
    March 26, 2015
    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 Cortex Manufacturing, Inc.

    K Number Device Name
    K102506 MIXED MEDIA MARKER
    K100267 FLEXIMARC, MODEL CM-0.9-2-10-GG-L