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

    TOMTEC-ARENA

    K Number: K213544 · Decision Jan 6, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    303
    Applicant Total
    21
    Review Days
    59

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    Basic Information

    Device Name
    TOMTEC-ARENA
    K Number
    K213544
    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
    November 8, 2021
    Decision Date
    January 6, 2022
    Product Code
    QIH
    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
    QIH Automated Radiological Image Processing Software

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    Other Clearances by Tomtec Imaging Systems GmbH

    K Number Device Name
    K201632 TOMTEC-ARENA
    K150122 TOMTEC-ARENA TTA2
    K132544 TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA
    K122289 IMAGE-COM 5.0
    K120135 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0
    K110746 4D LV-ANALYSIS 3.0
    K110667 IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS
    K110595 4D SONO-SCAN 1.0
    K103782 4D MV-ASSESSMENT 2.0
    K090461 IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0
    Search all 21 clearances from Tomtec Imaging Systems GmbH →