ACUSON Redwood Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.The ACUSON Redwood Diagnostic Ultrasound System is a multi-purpose ultrasound device designed for a wide range of clinical applications including fetal, abdominal, cardiac, vascular, musculoskeletal, and more. It uses advanced ultrasonic pulsed Doppler and various imaging modes to help healthcare professionals visualize internal body structures and measure anatomical features, assisting in clinical diagnosis and patient management, such as assessing liver fat content. It supports both 2D and advanced combined imaging modes and integrates specialized features like Ultrasound-Derived Fat Fraction (UDFF) for aiding in hepatic steatosis evaluation.
Intended Use
The ACUSON Redwood ultrasound imaging system is intended to provide images or signals from inside the body in clinical settings for fetal, abdominal, pediatric, small parts, OB/GYN, cardiac, pelvic, cephalic, vascular, musculoskeletal, transcranial, and peripheral vascular applications, including a measurement tool (UDFF) for aiding hepatic steatosis management.
Technology
The system is a mobile, software-controlled ultrasound device capable of multiple imaging modes including 2D, M-mode, Color Doppler, Pulsed and Continuous Wave Doppler, Harmonic imaging, and volume imaging. It uses proprietary software to acquire and display harmonic ultrasound echo data and supports measurement features like Auto IMT and UDFF. It operates with various transducers and integrates safety features based on standardized medical device safety and performance standards.
Performance
The device underwent acoustic output, biocompatibility, and safety testing per relevant standards. Clinical validation included two studies evaluating the UDFF measurement tool demonstrating excellent reliability, strong correlation with predicate devices, and good agreement with MRI-PDFF reference, without requiring additional clinical studies due to technological equivalence with predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/18/2024
28 days - 2
FDA Approval
11/15/2024
Other devices from Siemens Medical Solutions USA, Inc.
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