Mindray color ultrasounds system nets FDA clearance
Mindray Medical International Limited, a developer, manufacturer and marketer of medical devices, has received 510(k) clearance from the FDA for its DC-3 color ultrasound imaging system.
The clearance comes in addition to China State FDA approval and CE Mark granted earlier this year for the sale of the DC-3 in Chinese and European markets, respectively, according to the Shenzhen, China-based company.
The compact DC-3 combines 2D imaging and exceptional color Doppler performance, according to Li Xiting, Mindray's president and co-CEO.
Mindray said its DC-3 color ultrasound imaging system is designed to have applications in abdominal, OB/GYN, endovaginal, cardiac, small parts and pediatric markets. The product is suited for U.S. hospitals, doctors' offices and veterinary clinics seeking to replace black and white ultrasound imaging systems.
The clearance comes in addition to China State FDA approval and CE Mark granted earlier this year for the sale of the DC-3 in Chinese and European markets, respectively, according to the Shenzhen, China-based company.
The compact DC-3 combines 2D imaging and exceptional color Doppler performance, according to Li Xiting, Mindray's president and co-CEO.
Mindray said its DC-3 color ultrasound imaging system is designed to have applications in abdominal, OB/GYN, endovaginal, cardiac, small parts and pediatric markets. The product is suited for U.S. hospitals, doctors' offices and veterinary clinics seeking to replace black and white ultrasound imaging systems.