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

    4D MV-ASSESSMENT 2.0

    K Number: K103782 · Decision Jan 27, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    21
    Review Days
    31

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    Basic Information

    Device Name
    4D MV-ASSESSMENT 2.0
    K Number
    K103782
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tomtec Imaging Systems GmbH
    Date Received
    December 27, 2010
    Decision Date
    January 27, 2011
    Product Code
    DQK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQK Computer, Diagnostic, Programmable

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    Other Clearances by Tomtec Imaging Systems GmbH

    K Number Device Name
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    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
    K090461 IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0
    Search all 21 clearances from Tomtec Imaging Systems GmbH →