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

    4D LV-ANALYSIS 3.0

    K Number: K110746 · Decision May 24, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    21
    Review Days
    68

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    Basic Information

    Device Name
    4D LV-ANALYSIS 3.0
    K Number
    K110746
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tomtec Imaging Systems GmbH
    Date Received
    March 17, 2011
    Decision Date
    May 24, 2011
    Product Code
    DQK
    Advisory Committee
    Cardiovascular
    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
    DQK Computer, Diagnostic, Programmable

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    Other Clearances by Tomtec Imaging Systems GmbH

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    K132544 TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA
    K122289 IMAGE-COM 5.0
    K120135 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0
    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
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