BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Myocardial Strain Software Application

    K Number: K232661 · Decision Dec 7, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    2
    Review Days
    98

    Basic Information

    Device Name
    Myocardial Strain Software Application
    K Number
    K232661
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Circle Cardiovascular Imaging
    Date Received
    August 31, 2023
    Decision Date
    December 7, 2023
    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.

    CustomSurg OrthoPlanner

    FDA 510(k)
    FDA Class 2 ·Radiology

    uOmniscan

    FDA 510(k)
    FDA Class 2 ·Radiology

    Mosaic (V1.0.1)

    FDA 510(k)
    FDA Class 2 ·Radiology

    UroNav 4

    FDA 510(k)
    FDA Class 2 ·Radiology

    TechLive

    FDA 510(k)
    FDA Class 2 ·Radiology

    SMARTDent

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

    Other Clearances by Circle Cardiovascular Imaging

    K Number Device Name
    K241038 Cardiac CT Function Software Application