ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System
Siemens Medical Solutions, USA, Inc.The ACUSON Sequoia Diagnostic Ultrasound System family by Siemens Medical Solutions includes multi-purpose, software-controlled ultrasound systems designed to provide detailed images and measurements from inside the body. These systems support various clinical applications including fetal, abdominal, cardiac, musculoskeletal, and vascular imaging, among others. They assist clinicians by offering advanced imaging modes such as 2D, Doppler, elastography, and 3D/4D volume imaging, as well as specialized tools like Ultrasonically-Derived Fat Fraction (UDFF) for managing hepatic steatosis. The systems deliver real-time imaging and measurements to help diagnose and manage a wide range of conditions effectively.
Intended Use
Intended to provide images of or signals from inside the body by trained healthcare professionals in a clinical setting for a broad range of applications including fetal, abdominal, pediatric, cardiac, vascular, musculoskeletal, and other anatomical regions.
Technology
Software-controlled diagnostic ultrasound systems using multiple imaging modes such as 2D, Doppler (Pulsed Wave, Continuous Wave, Color flow), M-mode, elastography, 3D/4D volume imaging, and harmonic imaging. Incorporates proprietary software for advanced functions including Ultrasonically-Derived Fat Fraction measurement and cardiac anatomical and functional applications. Compatible with various transducers and catheters for intracardiac visualization.
Performance
Clinical validation data for the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool demonstrated acceptable accuracy and reliability in pediatric patients compared to MRI Proton Density Fat Fraction (MRI-PDFF), with high correlation (AUROC ≥ 0.87) and test-retest reliability (ICC ≥ 0.97). The exam time was less than 60 seconds, supporting clinical feasibility.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/14/2024
4 months - 2
FDA Approval
7/22/2024
Other devices from Siemens Medical Solutions, USA, Inc.
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