V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.The V8 and V7 Diagnostic Ultrasound Systems by Samsung Medison are advanced ultrasound machines designed for a wide range of clinical applications including fetal, abdominal, musculoskeletal, cardiac, and more. They use various ultrasound imaging modes and AI-based tools to assist healthcare professionals in acquiring and analyzing ultrasound images for improved diagnosis and workflow efficiency.
Intended Use
Designed to obtain ultrasound images and analyze body fluids with clinical applications in fetal/obstetrics, abdominal, gynecology, musculoskeletal, urology, cardiac, thoracic, and peripheral vessels.
Technology
The device is a software-controlled ultrasound system offering 2D, Doppler, elastography, and 3D/4D imaging modes. It incorporates AI-based features such as NerveTrack for nerve detection, BiometryAssist and ViewAssist for measurement and view recognition, and HeartAssist for cardiac imaging. It uses acoustic output displays and complies with recognized medical device safety standards.
Performance
Performance testing includes validation of AI algorithms including NerveTrack (90.3% accuracy), BiometryAssist (segmentation dice score 0.928), ViewAssist (view recognition accuracy 94.56%), and HeartAssist (view recognition accuracy up to 98.31%, segmentation dice scores up to 0.93). Testing used multi-center datasets with substantial expert annotation and separation of training and validation data sets. Non-clinical safety testing followed relevant FDA-recognized standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/7/2022
3 months - 2
FDA Approval
2/13/2023
Other devices from Samsung Medison Co., Ltd.
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