Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); Diagnost

The Recho R9W series is a general-purpose diagnostic ultrasound system intended for use by qualified healthcare professionals in hospitals and medical clinics. It is applicable for adults, pregnant women, pediatric patients, and neonates across multiple examination types including fetal, abdominal, cardiac, vascular, and musculoskeletal imaging. The system acquires and displays ultrasound images in multiple modes (B, M, PWD, CWD, Color Doppler, Tissue Harmonic Imaging, 3D/4D, Strain Elastography, Contrast imaging, and others) and provides measurement and analysis capabilities.

The subject device transmits ultrasonic energy into patients and performs post-processing of received echoes to generate onscreen anatomic displays. Its acoustic power levels are below FDA limits, matching predicate devices Resona R9 and EPIQ 7. Patient-contact materials are identical to predicates or tested under ISO 10993-1. The device includes new features such as Quick View (for Matrix 4D cardiac plane selection) and Auto Strain functions, which are enhancements of cleared capabilities from predicate devices QLab and EPIQ 7. It is designed to comply with FDA-recognized electrical and physical safety standards equivalent to predicate Resona R9.

NEMA UD 2-2004 (R2009) for acoustic output measurement; ANSI AAMI ES60601-1:2005 and amendments for medical electrical equipment safety; IEC 60601-1-2 Edition 4.1 for electromagnetic disturbances; IEC 60601-1-6 Edition 3.2 for usability; IEC 60601-2-37 Edition 2.1 for ultrasonic diagnostic equipment; ISO 14971 for risk management; ISO 10993-1 for biocompatibility; IEC 62304 for software lifecycle; IEC 62366-1 for usability engineering.

The subject device is substantially equivalent because it has the same intended uses, imaging modes, and technological characteristics as predicate Resona R9, with two exceptions already cleared in other predicates: thoracic/pleural application (cleared in TEX20) and Matrix 4D function (cleared in EPIQ 7). All new features represent enhancements or refinements of previously cleared capabilities rather than new intended uses. Acoustic power, biocompatibility, electrical safety, and design compliance all meet or match predicate standards. The device does not introduce novel clinical risks and performs the same fundamental function—transmitting ultrasonic energy and processing echoes for diagnostic imaging.