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 imaging systems designed for a wide range of clinical applications including obstetrics, abdominal, cardiac, musculoskeletal and more. They produce ultrasound images and enable fluid analysis, incorporating features like Doppler imaging and AI-supported nerve detection to help clinicians make accurate diagnoses in real-time.
Intended Use
The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids for various clinical applications including fetal/obstetrics, abdominal, gynecology, intra-operative, pediatric, small organ, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, urology, cardiac adult and pediatric, thoracic, trans-esophageal cardiac and peripheral vessels, for clinical diagnosis under supervision of qualified healthcare professionals.
Technology
The V8 and V7 ultrasound systems are mobile, software-controlled devices that acquire ultrasound data and display images in multiple modes including 2D, Color Doppler, Power Doppler, M-mode, Pulsed Wave Doppler, Continuous Wave Doppler, Tissue Doppler Imaging, ElastoScan, multi-image and 3D/4D. They also provide measurement and analysis capabilities and display real-time acoustic output indices. The AI-based NerveTrack feature supports nerve detection in expanded nerve types, validated with performance testing.
Performance
The device underwent extensive non-clinical testing including acoustic output, biocompatibility, software function, cleaning and safety tests complying with FDA-recognized standards. The AI NerveTrack algorithm was validated on a dataset of 18 subjects with accuracy of 91.7% and speed of 7.93 frames per second, showing robust performance across BMI subgroups. Experienced anesthesiologists established ground truth for nerve locations. No new clinical studies were required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/4/2022
2 months - 2
FDA Approval
6/29/2022
Other devices from Samsung Medison Co., Ltd.
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