BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)

    K Number: K253288 · Decision Apr 6, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    67
    Review Days
    189

    Basic Information

    Device Name
    6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
    K Number
    K253288
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Esaote, S.p.A.
    Date Received
    September 29, 2025
    Decision Date
    April 6, 2026
    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

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    Other Clearances by Esaote, S.p.A.

    K Number Device Name
    K260746 S-scan Open (100001800)
    K251901 Magnifico Open (100009900)
    K253310 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
    K243253 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)
    K241671 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
    K241133 Magnifico Open (100009900); Magnifico MSK ( 100009910)
    K230179 6440 MyLabX90
    K212419 Magnifico Open, Magnifico MSK
    K212021 6430 MyLabX75, 6430 MyLab XPro75
    K192157 6450 Ultrasound system
    Search all 67 clearances from Esaote, S.p.A. →