Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System
Shenzhen Mindray Bio-medical Electronics Co., LTD.The Resona A10S and related series are advanced diagnostic ultrasound systems used by healthcare professionals to acquire, display, and analyze ultrasound images and measurements of the human body. The system supports a wide range of ultrasound imaging modes and can be used in diverse clinical applications such as cardiac, abdominal, gynecologic, and musculoskeletal exams, thus aiding clinicians in diagnosis and patient care.
Intended Use
General purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid in a hospital or medical clinic setting. It is applicable for adults, pregnant women, pediatric patients and neonates across multiple exam types including ophthalmic, fetal, abdominal, musculo-skeletal, gynecological, cardiac, and peripheral vessel exams.
Technology
A mobile, software-controlled ultrasonic diagnostic system capable of multiple imaging modes including B-mode, M-mode, pulsed wave Doppler, color Doppler, power Doppler, combined modes, tissue harmonic imaging, 3D/4D real-time imaging, strain elastography, and contrast imaging. It also includes advanced functionalities such as super resolution contrast-enhanced ultrasound, sound touch viscoelastography, and volume data export for enhanced diagnostic and research purposes.
Performance
The device underwent comprehensive non-clinical testing for acoustic output, biocompatibility, cleaning and disinfection, thermal, electrical and mechanical safety, and complies with multiple international standards (e.g., NEMA, IEC, ISO). Clinical studies were not required as substantial equivalence to predicate devices was demonstrated.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/30/2024
3 months - 2
FDA Approval
11/8/2024
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