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

The Resona A10S, Resona A20 series, and Eagus A20 Diagnostic Ultrasound Systems are general-purpose diagnostic ultrasound devices for imaging, measurement, display, and analysis of the human body and fluid. They are intended for use by qualified healthcare professionals in hospitals or medical clinics for various applications including ophthalmic, fetal, abdominal, cardiac, pediatric, and musculoskeletal exams in adults, pregnant women, pediatric patients, and neonates.

The devices operate in multiple modes including B, M, PWD, CWD, Color Doppler, Power Doppler, Tissue Harmonic Imaging, 3D/4D imaging, Strain Elastography, and Contrast imaging with various contrast agents. Acoustic power levels are below FDA-recommended limits and match the predicate device. Patient contact materials of transducers are the same as or biocompatible under ISO 10993-1. A new SonoLink remote maintenance function is included for remote troubleshooting by authorized service engineers.

NEMA UD 2-2004 (acoustic output), ANSI AAMI ES60601-1:2005 (electrical safety), IEC 60601-1-2 (electromagnetic immunity), IEC 60601-1-6 (usability), IEC 60601-2-37 (ultrasonic equipment safety), ISO 14971 (risk management), ISO 10993-1 (biocompatibility), IEC 62304 (software life cycle), and IEC 62366-1 (usability engineering).

The subject devices have the same intended uses as the predicate Resona A10S (K242231), except intra-operative applications and pediatric contrast imaging, which are cleared in other reference devices. All systems transmit ultrasonic energy, process echoes for anatomic display, and perform measurements. The devices are designed with equivalent features and functions, use the same patient contact materials or biocompatible alternatives, maintain acoustic power levels consistent with the predicate, and comply with the same electrical and physical safety standards.