HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.The HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System by Samsung Medison Co., Ltd. is a versatile ultrasound imaging system used by healthcare professionals to obtain and analyze ultrasound images and body fluids. It offers multiple imaging modes including 2D, Color Doppler, Power Doppler, M mode, Pulsed and Continuous Wave Doppler, Tissue Doppler Imaging, and advanced AI-based features such as BiometryAssist, HeartAssist, ViewAssist, and others to aid in image recognition, measurement, and workflow efficiency. It is intended for clinical use in various applications including fetal, abdominal, cardiac, musculoskeletal, and more.
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 imaging.
Technology
The device is a general purpose, mobile, software-controlled diagnostic ultrasound system acquiring ultrasound data in various modes including 2D, Color Doppler, Power Doppler, M mode, Pulsed and Continuous Wave Doppler, Tissue Doppler Imaging/Wave, ElastoScan, MV-Flow, Multi-Image, and 3D/4D. AI-based features include BiometryAssist, HeartAssist, ViewAssist, EzVolume, Live ViewAssist, UterineContour, and SonoSync for improved workflow and image analysis. New transducers and WiFi module are included.
Performance
Performance testing included validation of AI algorithms on view recognition, quality assessment, segmentation, and measurement across large, diverse datasets. Clinical experts performed manual annotations for ground truths. Test results showed high accuracy, with dice scores over 0.87 for segmentation tasks and recognition accuracies exceeding 94%. Safety and compliance testing confirmed conformance to applicable FDA recognized standards and safety limits.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/5/2024
3 months - 2
FDA Approval
10/11/2024
Other devices from Samsung Medison Co., Ltd.
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.