BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Labat series Diagnostic Ultrasound System

    K Number: K210154 · Decision Jul 30, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    1117
    Applicant Total
    1
    Review Days
    190

    Basic Information

    Device Name
    Labat series Diagnostic Ultrasound System
    K Number
    K210154
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Wisonic Medical Technology Co.,Ltd.
    Date Received
    January 21, 2021
    Decision Date
    July 30, 2021
    Product Code
    IYN
    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
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

    Similar 510(k) Clearances

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

    Sonosite LX Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vivid Pioneer

    FDA 510(k)
    FDA Class 2 ·Radiology

    EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

    FDA 510(k)
    FDA Class 2 ·Radiology

    6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)

    FDA 510(k)
    FDA Class 2 ·Radiology

    TE Air Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Voluson™ Performance 16; Voluson™ Performance 18

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