HS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.The HS40 Diagnostic Ultrasound System by Samsung Medison is a general-purpose, mobile ultrasound device designed to acquire and display ultrasound images and analyze body fluids. It supports multiple imaging modes including 2D, 3D/4D, Doppler, and elastography, and incorporates AI-based features such as NerveTrack for nerve detection and UterineAssist for uterus segmentations to aid clinicians in diagnosis and procedural guidance.
Intended Use
The HS40 diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids for clinical applications including fetal/obstetrics, abdominal, gynecology, pediatric, small organ, neonatal and adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, urology, cardiac (adult and pediatric), and peripheral vessel imaging.
Technology
HS40 is a mobile, software-controlled diagnostic ultrasound system capable of multiple imaging modes including 2D, M mode, Color Doppler, Power Doppler, Spectral Doppler, Harmonic imaging, Tissue Doppler, Elastography, and multi-image modes. It integrates AI-based features such as NerveTrack for nerve detection and UterineAssist for uterus segmentation and feature point extraction. It supports various types of transducers and ensures user safety by meeting acoustic power limits and international safety standards.
Performance
The device underwent extensive non-clinical testing including acoustic output, biocompatibility, software validation, cleaning, disinfection, and safety evaluations compliant with recognized international standards. AI component validation demonstrated the NerveTrack feature achieved 91.7% accuracy and 7.93 frames per second speed on diverse datasets. UterineAssist segmentation showed high accuracy with Dice scores up to 96%, feature point errors below 6 mm, and measurement errors under 2 mm.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/2/2022
2 months - 2
FDA Approval
8/22/2022
Other devices from Samsung Medison Co., Ltd.
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