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

    3D Echo

    K Number: K172513 · Decision Sep 14, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    3
    Review Days
    24

    Basic Information

    Device Name
    3D Echo
    K Number
    K172513
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    JointVue LLC
    Date Received
    August 21, 2017
    Decision Date
    September 14, 2017
    Product Code
    LLZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    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 JointVue LLC

    K Number Device Name
    K211656 3D Echo v1.1
    K173329 jFit Surgical Planner