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

    Sonosite MT Ultrasound System

    K Number: K253448 · Decision Nov 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    25
    Review Days
    32

    Basic Information

    Device Name
    Sonosite MT Ultrasound System
    K Number
    K253448
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    FUJIFILM Sonosite, Inc.
    Date Received
    October 2, 2025
    Decision Date
    November 3, 2025
    Product Code
    IYN
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    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 FUJIFILM Sonosite, Inc.

    K Number Device Name
    K260595 Sonosite iLOOK Ultrasound System
    K251106 Sonosite LX and Sonosite PX Ultrasound Systems
    K251830 Sonosite LX Ultrasound System
    K233597 Sonosite LX Ultrasound System
    K213763 Sonosite PX Ultrasound System
    K202160 Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System
    K200964 Sonosite PX Ultrasound System
    K190476 FUJIFILM Sonosite Vevo MD Imaging System
    K183235 SonoSite SII Ultrasound System
    K180704 SonoSite iViz Ultrasound System
    Search all 25 clearances from FUJIFILM Sonosite, Inc. →