BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    EzOrtho v1.3

    K Number: K220003 · Decision Feb 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    10
    Review Days
    50

    Basic Information

    Device Name
    EzOrtho v1.3
    K Number
    K220003
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ewoosoft Co., Ltd
    Date Received
    January 4, 2022
    Decision Date
    February 23, 2022
    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 Ewoosoft Co., Ltd

    K Number Device Name
    K250005 Clever One
    K231757 Ez3D-i /E3
    K230468 EzDent Web
    K223820 EzDent-i / E2 / Prora View/ Smart M Viewer
    K222069 Ez3D-i/E3
    K222145 EzDent-i / E2 / Prora View/ Smart M Viewer
    K211700 EzDent Web
    K211793 EzOrtho
    K211791 Ez3D-i/E3