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, Sequoia Select, Origin, and Origin ICE Diagnostic Ultrasound Systems by Siemens are advanced diagnostic ultrasound devices that provide detailed imaging and signal data inside the body for clinical diagnosis. They are intended for a wide range of clinical applications including fetal, abdominal, cardiac, vascular, musculoskeletal, and pediatric imaging. These systems integrate AI-powered tools such as AI Abdomen for semi-automated view classification and measurement in abdominal ultrasound, and Trace AI for semi-automated measurements of anatomical structures in cardiac imaging, improving efficiency and accuracy for clinicians.
Intended Use
The ACUSON Sequoia and Sequoia Select ultrasound imaging systems provide images or signals from inside the body by trained healthcare professionals for fetal, abdominal, pediatric, neonatal cephalic, small parts, OB/GYN, cardiac, transesophageal, pelvic, vascular, adult cephalic, musculoskeletal, and peripheral vascular applications. They support tools such as Ultrasonically-Derived Fat Fraction measurement for hepatic steatosis and tools to measure anatomical structures for clinical diagnosis. The Origin and Origin ICE systems also provide intracardiac and intra-luminal visualization for cardiac and vessel anatomy during interventional procedures.
Technology
These ultrasound systems are multi-mode, mobile, software-controlled devices using 2D, 3D/4D volume imaging, Doppler imaging (color, pulsed wave, continuous wave), elastography (strain and shear wave), harmonic imaging, and combined modes. They utilize proprietary software incorporating AI algorithms for semi-automated classification and measurement tasks. The systems comply with multiple international safety and performance standards and include features for measuring anatomical structures adjunctively with clinical data.
Performance
Performance testing included evaluation of AI Abdomen and Trace AI algorithms. AI Abdomen achieved a view classification success rate of 77.8% across 17 abdomen views, improving to 82.5% excluding difficult views, and met equivalence criteria for semi-automated measurements (IEC <0.25). Trace AI met accuracy goal with a minimum Dice coefficient of 0.95 surpassing the 0.8 requirement on volumetric cardiac imaging structures. Testing datasets included multiple institutions, transducers, and patient demographics ensuring broad representative performance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/23/2024
2 months - 2
FDA Approval
11/19/2024
Other devices from Siemens Medical Solutions USA, Inc.
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