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

    LVIVO EF SYSTEM

    K Number: K130779 · Decision Aug 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    2
    Review Days
    147

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    LVIVO EF SYSTEM
    K Number
    K130779
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diacardio, Ltd.
    Date Received
    March 21, 2013
    Decision Date
    August 15, 2013
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LLZ), ordered by most recent decision date.

    2D Hip Planning Software

    FDA 510(k)
    FDA Class 2 ·Radiology

    CustoMED Viewer

    FDA 510(k)
    FDA Class 2 ·Radiology

    Helion Viewer Suite

    FDA 510(k)
    FDA Class 2 ·Radiology

    CMN Capillary Function with Virtual Expert for MRI, CT and CBCT

    FDA 510(k)
    FDA Class 2 ·Radiology

    SubtleHD-PET (1.x)

    FDA 510(k)
    FDA Class 2 ·Radiology

    HipGuide (V 1.0.0.0)

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    Other Clearances by Diacardio, Ltd.

    K Number Device Name
    K161382 LVivo Software Application