V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.The V5 and H5 series diagnostic ultrasound systems from Samsung Medison are advanced ultrasound imaging devices that provide real-time images and Doppler analysis to assist healthcare professionals in clinical diagnosis across a broad range of applications including obstetrics, cardiology, musculoskeletal, and dermatology. These systems use AI-powered tools for tasks like view recognition, segmentation, and measurement, enhancing accuracy and efficiency in ultrasound examinations.
Intended Use
The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids in various clinical applications including fetal/obstetrics, abdominal, gynecology, pediatric, cardiac, musculoskeletal, dermatology and others.
Technology
The system is a general purpose, mobile, software-controlled diagnostic ultrasound system that acquires ultrasound data and displays it in multiple modes including 2D, color Doppler, power Doppler, M-mode, pulsed wave Doppler, continuous wave Doppler, tissue Doppler imaging, elastography, 3D/4D modes, and more. It includes AI-powered analysis packages for measurements and diagnostics and features a real-time acoustic output display.
Performance
Performance testing included validation of multiple AI-powered features such as HeartAssist (view recognition, segmentation, size measurement), BiometryAssist, ViewAssist, UterineAssist and NerveTrack (nerve detection and segmentation). Testing used thousands of clinical images across multiple hospitals with high accuracy metrics reported, e.g., 93-98% accuracy in view recognition and segmentation, and measurement error rates within clinically acceptable margins.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/23/2024
3 months - 2
FDA Approval
12/10/2024
Other devices from Samsung Medison Co., Ltd.
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