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 devices for diagnostic imaging and fluid analysis of the human body. They support numerous clinical applications including fetal, abdominal, cardiac, musculoskeletal, and vascular imaging. These systems incorporate various imaging modes such as 2D, 3D, Doppler, and elastography, and include AI-powered features like BiometryAssist and ViewAssist that help with anatomical measurements and view recognition, aiding clinicians in making accurate diagnoses.
Intended Use
The Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body across multiple clinical applications including fetal/obstetrics, abdominal, gynecology, pediatric, musculoskeletal, cardiac, and peripheral vessels.
Technology
Mobile, software-controlled diagnostic ultrasound system acquiring and displaying ultrasound data in multiple modes including B-mode, M-mode, Pulsed Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging, 3D/4D imaging, ElastoScan+, and AI-powered analysis packages such as BiometryAssist for automated anatomical measurements and ViewAssist for view recognition and annotation. Includes a real-time acoustic output display with mechanical and thermal indices for safety.
Performance
Software performance testing included validation of AI segmentation and measurement algorithms (BiometryAssist) on 320 fetal biometry images and AI-based view recognition and anatomy annotation (ViewAssist) on 1,320 fetal heart and biometry images, achieving high accuracy and dice scores above thresholds. The device complied with recognized safety standards for electrical, thermal, mechanical, and acoustic outputs. The device passed risk analysis, software and system verification and validation, and image quality tests. Biocompatibility and cleaning/disinfection effectiveness were also evaluated.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/11/2023
3 months - 2
FDA Approval
4/21/2023
Other devices from Samsung Medison CO., LTD.
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