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510(k) Data Aggregation

    K Number
    K253448

    Validate with FDA (Live)

    Date Cleared
    2025-11-03

    (32 days)

    Product Code
    Regulation Number
    892.1550
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sonosite MT Ultrasound System is a general-purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:

    • Abdominal
    • Adult Cephalic
    • Cardiac Adult
    • Cardiac Pediatric
    • Fetal-OB/GYN
    • Musculo-skeletal (Conventional)
    • Musculo-skeletal (Superficial)
    • Ophthalmic
    • Pediatric
    • Peripheral Vessel
    • Small Organ (breast, thyroid, testicles, prostate)
    • Transvaginal
    • Needle Guidance

    Modes of operation include: B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M Mode), PW Doppler (PWD) (including High Pulse Repetition Frequency (HPRF) and simultaneous PWD for certain exam types), Tissue Doppler Imaging (TDI), Continuous Wave Doppler (CWD), Color Power Doppler, Velocity Color Doppler, Color Variance, Tissue Harmonic Imaging (THI), Multi-beam imaging, Steep Needle Profiling, Trapezoid, and combined modes, including duplex and triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD.

    This device is indicated for Prescription Use Only.

    The Sonosite MT Ultrasound System is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.

    The system is used with a transducer attached and is powered either by battery or by AC electrical power. The clinician is positioned next to the patient and places the transducer onto the patient's body where needed to obtain the desired ultrasound image.

    Device Description

    The Sonosite MT is a high-resolution, portable and versatile ultrasound system designed for use on a stand and easy grab-and-go deployment. It is a fully featured, general purpose, software controlled, diagnostic ultrasound system using all digital architecture.

    The system is used to acquire and display high-resolution, real-time ultrasound data in B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler (PWD) (including High Pulse Repetition Frequency (HPRF) and simultaneous PWD for certain exam types), Tissue Doppler Imaging (TDI), Continuous Wave Doppler (CWD), Color Power Doppler, Velocity Color Doppler, Color Variance, Tissue Harmonic Imaging (THI), Multi-beam imaging, Steep Needle Profiling, Trapezoid, and combined modes, including duplex and triplex imaging.

    The system includes a variety of accessories including needle guide starter kits (optional). The system also includes an ECG-specific port to support the ECG feature. The non-diagnostic ECG module provides ECG tracing of the cardiac signal synchronized with the ultrasound image. ECG is available only with cardiac exam types with the P5-1 transducer. Sonosite MT also features a Triple Transducer Connect (TTC) that allows simultaneous connection of three transducers to the system. The system also includes an I/O hub to facilitate connection to a network using an Ethernet connection. The I/O hub includes three USB 2.0 ports to connect with the accessories and one USB 3.0 plug to connect the module with the system. Sonosite MT system features a battery charge indicator presented by four LED lights and a scan time remaining display that indicates the battery charge level.

    AI/ML Overview

    N/A

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