BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    TOMTEC-ARENA

    K Number: K201632 · Decision Aug 14, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    2
    Review Days
    59

    Basic Information

    Device Name
    TOMTEC-ARENA
    K Number
    K201632
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    TOMTEC Imaging Systems GmbH
    Date Received
    June 16, 2020
    Decision Date
    August 14, 2020
    Product Code
    LLZ
    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
    LLZ System, Image Processing, Radiological

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    Other Clearances by TOMTEC Imaging Systems GmbH

    K Number Device Name
    K213544 TOMTEC-ARENA