HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System
Samsung Medison Co., LTDThe HERA W9 and HERA W10 Diagnostic Ultrasound Systems by Samsung Medison are advanced ultrasound machines designed to capture and display ultrasound imaging including B-mode, Doppler modes, 3D/4D imaging, and provide measurement and analysis tools to assist healthcare professionals in diagnosing various conditions. They support a wide range of clinical applications such as fetal, abdominal, cardiac, musculoskeletal, and more, helping clinicians in hospitals and clinics perform accurate diagnostic imaging and fluid analysis efficiently.
Intended Use
The diagnostic ultrasound system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
Technology
The HERA W9/HERA W10 are general purpose, mobile, software controlled, diagnostic ultrasound systems that acquire ultrasound data and display it in various modes including B-mode, M-mode, Doppler modes, 3D/4D imaging, and combined modes. They include analysis packages and real-time acoustic output display with mechanical and thermal indices.
Performance
The device was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic and mechanical safety, complying with applicable medical device safety and quality standards. Software verification and validation, system verification, and image quality tests were also conducted. Clinical studies were not required for this submission.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/5/2022
3 months - 2
FDA Approval
4/5/2022
Other devices from Samsung Medison Co., LTD
- V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System2024 • 510K
- HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System2024 • 510K
- HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System2024 • 510K
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