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

    S-scan Open (100001800)

    K Number: K260746 · Decision Mar 27, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    1098
    Applicant Total
    67
    Review Days
    21

    Basic Information

    Device Name
    S-scan Open (100001800)
    K Number
    K260746
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Esaote, S.p.A.
    Date Received
    March 6, 2026
    Decision Date
    March 27, 2026
    Product Code
    LNH
    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
    LNH System, Nuclear Magnetic Resonance Imaging

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    Other Clearances by Esaote, S.p.A.

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    K253310 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
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    K241671 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
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    K212419 Magnifico Open, Magnifico MSK
    K212021 6430 MyLabX75, 6430 MyLab XPro75
    K192157 6450 Ultrasound system
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