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

    6430 MyLabX75, 6430 MyLab XPro75

    K Number: K212021 · Decision Sep 16, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    67
    Review Days
    80

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    Basic Information

    Device Name
    6430 MyLabX75, 6430 MyLab XPro75
    K Number
    K212021
    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
    June 28, 2021
    Decision Date
    September 16, 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

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    Other Clearances by Esaote, S.p.A.

    K Number Device Name
    K253288 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
    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
    K192157 6450 Ultrasound system
    Search all 67 clearances from Esaote, S.p.A. →