V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.The V8 Diagnostic Ultrasound System and its variants are advanced ultrasound imaging devices designed to capture and analyze ultrasound images, including 2D, Doppler modes, and 3D/4D images. They assist healthcare professionals in diagnosing a wide range of medical conditions across various body regions by providing real-time imaging and measurement capabilities with AI-supported features such as nerve tracking and cardiac strain analysis.
Intended Use
The diagnostic ultrasound system and probes 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, urology, cardiac adult and pediatric, thoracic, trans-esophageal cardiac, and peripheral vessel.
Technology
The system is a general purpose, mobile, software-controlled diagnostic ultrasound system that operates in 2D, Doppler, M mode, tissue Doppler imaging, elastography, combined modes, multi-image (dual, quad), and 3D/4D modes. It includes AI-supported analysis packages such as EzNerveMeasure for nerve segmentation and AutoEF for cardiac function measurement, incorporating real-time acoustic output display with mechanical and thermal indices.
Performance
The device underwent extensive non-clinical testing including acoustic output, biocompatibility, software function, cleaning and disinfection effectiveness, and safety standards compliance. The AI-based EzNerveMeasure function was validated using 100 median nerve images with error rates approximately 8.31% for flattening ratio and 13.12% for cross-sectional area, using expert-labeled ground truth data. Clinical testing was not required for demonstration of substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/29/2024
2 months - 2
FDA Approval
2/12/2025
Other devices from Samsung Medison Co., Ltd.
- V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System2025 • 510K
- 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 System2024 • 510K
- HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System2024 • 510K
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