Mindray Receives Multiple Approvals

China’s Mindray Medical International has received 510(k) clearance from the FDA for its portable M5 ultrasound imaging system and BS-200 automatic biochemistry analyzer. Chinese regulators also have approved the M5 and the company’s DC-3 color ultrasound imaging system.

The DC-3 system is designed for abdominal, gynecological, endovaginal and cardiac procedures and is suited for hospitals and clinics seeking to replace black and white ultrasound imaging systems.

Mindray said it has approval for 14 products in the U.S., including patient monitoring and life-support products, in vitro diagnostic products and medical imaging systems.