HERA W9, HERA W10 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 across multiple clinical applications including fetal, abdominal, cardiac, and musculoskeletal imaging. They incorporate AI-powered features such as HeartAssist and BiometryAssist to improve efficiency and accuracy by automatically identifying scanning views and aiding biometric measurements. These devices assist clinicians by providing comprehensive ultrasound imaging modes and enhancing workflow in hospitals and clinics.
Intended Use
The diagnostic ultrasound system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body across a wide range of clinical applications including Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Muscular-Skeletal, Urology, Cardiac, and Peripheral vessel.
Technology
The system is a mobile, software-controlled diagnostic ultrasound system that acquires ultrasound data and displays it through multiple modes such as B-mode, Doppler modes, Tissue Doppler Imaging, ElastoScan+, and 3D/4D imaging. It features AI-powered software functions like HeartAssist for fetal heart scanning and BiometryAssist for biometric measurements, using deep learning to classify images and assist measurements to improve exam efficiency.
Performance
Performance testing included acoustic output, biocompatibility, electrical and safety standards compliance, software verification and validation, image quality tests, and testing of AI-based features (HeartAssist, ViewAssist, Slice A, and BiometryAssist). The new AI functions passed predefined criteria and the device met all image quality and safety standards without requiring clinical studies for equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/14/2021
2 months - 2
FDA Approval
9/9/2021
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