V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.The V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System by Samsung Medison Co., Ltd. is a general-purpose diagnostic ultrasound system that acquires ultrasound data and displays it in multiple modes including 2D, Doppler, and 3D/4D. It helps healthcare professionals with imaging and fluid flow analysis across many clinical applications such as fetal, cardiac, abdominal, and musculoskeletal imaging. The system includes AI-based features such as NerveTrack for nerve segmentation, enhancing diagnostic capabilities.
Intended Use
The diagnostic ultrasound system and transducers are designed to obtain ultrasound images and analyze body fluids for a variety of clinical applications including fetal/obstetrics, abdominal, gynecology, intra-operative, pediatric, musculoskeletal, cardiac (adult and pediatric), thoracic, trans-esophageal cardiac, and peripheral vessels.
Technology
The system is a mobile, software-controlled diagnostic ultrasound device that supports multiple imaging and Doppler modes including 2D, color Doppler, power Doppler, pulsed and continuous wave Doppler, tissue Doppler imaging/wave, ElastoScan, combined modes, and 3D/4D imaging. It incorporates AI-based nerve segmentation (NerveTrack) validated on diverse patient data, providing real-time acoustic output display and advanced imaging features.
Performance
Performance testing included validation of the AI-based NerveTrack segmentation algorithm with accuracy >90% and speed >3.6 FPS across BMI subgroups. Segmentation accuracy was above 98% with clinical ground truth established by experienced anesthesiologists and sonographers. Non-clinical tests covered acoustic output, biocompatibility, software validation, electrical, mechanical and electromagnetic safety, all meeting applicable FDA standards. No new clinical studies were required for substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/6/2024
3 months - 2
FDA Approval
6/21/2024
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