V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.The Samsung V8/H8, V7/H7, and V6/H6 Diagnostic Ultrasound Systems are advanced ultrasound machines designed to obtain and analyze ultrasound images and body fluids. They support a wide range of clinical applications such as fetal/obstetrics, abdominal, gynecology, cardiac, musculoskeletal, and vascular imaging. The systems offer multiple imaging modes including 2D, Doppler, ElastoScan, and 3D/4D modes, helping healthcare professionals diagnose patients more effectively. An AI-based feature called NerveTrack provides segmentation of nerves during ultrasound examinations, aiding in procedures involving nerve identification.
Intended Use
The diagnostic ultrasound system and transducers are designed to obtain ultrasound images and analyze body fluids. Clinical applications include fetal/obstetrics, abdominal, gynecology, intra-operative, pediatric, small organ, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional, superficial), urology, cardiac adult and pediatric, thoracic, trans-esophageal (cardiac), and peripheral vessel.
Technology
General purpose, mobile, software controlled diagnostic ultrasound system with multiple imaging modes such as 2D, Color Doppler, Power Doppler, M mode, Pulsed and Continuous Wave Doppler, Tissue Doppler Imaging, ElastoScan, Multi-Image, and 3D/4D modes. AI-based NerveTrack segmentation feature added for nerve detection and segmentation during pre-injection procedures. The system incorporates new and migrated transducers and biopsy guides. Adheres to relevant FDA-recognized standards for safety and performance.
Performance
Non-clinical testing included acoustic output, biocompatibility, software function, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety. The AI NerveTrack feature was validated with an accuracy of 90.3% (segmentation accuracy 98.69%) and processing speed around 3.6 FPS. Testing included datasets with diverse BMI ranges and analyzed performance robustness. Clinical studies were not required to demonstrate substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/16/2023
3 months - 2
FDA Approval
10/3/2023
Other devices from Samsung Medison Co., Ltd.
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