HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.The HERA W9 and HERA W10 Diagnostic Ultrasound Systems by Samsung Medison are advanced ultrasound imaging devices used to visualize and analyze structures within the human body. They support diverse clinical applications including obstetrics, cardiology, abdominal imaging, and musculoskeletal imaging through multiple ultrasound modes such as 2D, Doppler, and 3D/4D. The systems incorporate AI technologies to assist clinicians in fetal biometry and cardiac view recognition, helping improve diagnostic accuracy and workflow efficiency.
Intended Use
The Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. Clinical applications include fetal/obstetrics, abdominal, gynecology, pediatric, small organ, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, urology, cardiac (adult and pediatric), and peripheral vessels.
Technology
The HERA W9 and W10 are mobile, software-controlled diagnostic ultrasound systems that acquire ultrasound data and display them in various modes including B-mode, M-mode, Pulsed Wave and Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging, Power Doppler, Harmonic Imaging, 3D/4D, and ElastoScan+. They employ AI algorithms for measurement (BiometryAssist), view recognition (HeartAssist), and image viewing support (SonoSync). They comply with recognized safety standards and include acoustic power monitoring.
Performance
Performance testing included validation of AI-based algorithms for fetal heart view recognition, segmentation, and size measurement with high accuracy (around 95% view recognition accuracy, dice scores near 0.9 for segmentation). Testing used hundreds of fetal images and included demographic diversity and data separation for training and validation. The device also passed electrical, mechanical, thermal, and electromagnetic safety tests.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/16/2024
3 months - 2
FDA Approval
11/27/2024
Other devices from Samsung Medison Co., Ltd.
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