RS85 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.The RS85 Diagnostic Ultrasound System by Samsung Medison is a versatile diagnostic ultrasound device used in a variety of clinical applications such as obstetrics, abdominal, cardiac, musculoskeletal, and peripheral vessel imaging. It provides multiple imaging modes including 2D, Doppler, and 3D/4D imaging and incorporates AI technology for nerve detection and segmentation to aid clinicians in diagnosis and procedures. This system helps healthcare professionals obtain high-quality ultrasound images and quantitative analysis to improve patient care.
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, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, urology, cardiac adult and pediatric, trans-esophageal (cardiac), and peripheral vessel imaging.
Technology
RS85 is a software-controlled diagnostic ultrasound system capable of multiple ultrasound imaging modes (2D, M mode, Color Doppler, PW Doppler, CW Doppler, Tissue Doppler, Power Doppler, ElastoScan, Multi-Image, 3D/4D, and combined modes). It includes AI-based nerve detection and segmentation algorithms (NerveTrack), integrated power supply options, and a 27 inch OLED monitor for image viewing.
Performance
The device underwent non-clinical acoustic output, biocompatibility, cleaning, thermal, electrical, electromagnetic, and mechanical safety testing according to recognized standards. AI-based nerve detection was validated with 3,999 nerve images showing an average accuracy of 89.6% and average speed of 14.49 fps. AI-based nerve segmentation was validated with 1,753 images achieving a Dice similarity coefficient of 90.44%. Measurement accuracy for nerve features (flattening ratio and cross-sectional area) was also validated with error rates below 10%.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/23/2024
3 months - 2
FDA Approval
6/12/2024
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