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
Shenzhen Mindray Bio-medical Electronics Co., Ltd.The Diagnostic Ultrasound System (including models Recho R9W, Recho R9, and others) by Shenzhen Mindray Bio-medical Electronics Co., Ltd. is a general-purpose, mobile ultrasound imaging system. It helps trained healthcare professionals acquire and display ultrasound images in multiple modes like B, M, Doppler, 3D/4D, elastography, and contrast imaging, aiding in the diagnosis and analysis of various body regions in adults, pediatric patients, pregnant women, and neonates.
Intended Use
General purpose diagnostic ultrasound system intended for imaging, measurement, display and analysis of human body and fluid for adults, pregnant women, pediatric patients and neonates, across multiple anatomical regions including fetal, abdominal, thoracic, vascular, pediatric small organs, cardiac, musculoskeletal, pleural, and urology exams.
Technology
Mobile, software-controlled ultrasonic diagnostic system capable of multiple imaging modes including B, M, PW Doppler, Color Doppler, Amplitude Doppler, Combined modes, Tissue Harmonic Imaging, 3D/4D, elastography, contrast imaging, and analysis packages for anatomical measurements.
Performance
The device underwent extensive non-clinical testing including acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical and mechanical safety, and conformance with multiple medical electrical equipment standards (IEC 60601 series, ISO 10993-1, ISO 14971, IEC 62304, IEC 62366-1). Clinical studies were not required to demonstrate substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/3/2025
4 months - 2
FDA Approval
5/19/2025
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