BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LOGIQ Totus

    K Number: K253370 · Decision Jan 8, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    65
    Review Days
    100

    Basic Information

    Device Name
    LOGIQ Totus
    K Number
    K253370
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GE Medical Systems Ultrasound and Primary Care Diagnostics
    Date Received
    September 30, 2025
    Decision Date
    January 8, 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 GE Medical Systems Ultrasound and Primary Care Diagnostics

    K Number Device Name
    K260398 LOGIQ e
    K260673 LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power
    K253366 LOGIQ Fortis
    K252328 Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
    K251985 LOGIQ E10
    K251963 LOGIQ E10s
    K251322 Venue; Venue Go; Venue Fit; Venue Sprint
    K251342 EchoPAC Software Only / EchoPAC Plug-in
    K251169 Vivid Pioneer
    K250543 Voluson™ Performance 16; Voluson™ Performance 18
    Search all 65 clearances from GE Medical Systems Ultrasound and Primary Care Diagnostics →