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

About This 510(k) Submission

K250020 is an FDA 510(k) clearance for the 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, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 19, 2025, 136 days after receiving the submission on January 3, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.