Ultrasound Biotechnology, the Shanghai-based wholly owned subsidiary of US firm Ultrasound Wondering, Inc., has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its “Endoscopic ultrasound diagnostic equipment and disposable sterile endoscopic ultrasound probes” product. This marks a significant milestone as the company becomes the first manufacturer to utilize disposable endoscopic ultrasound probes with endoscopic ultrasound diagnostic equipment for clinical diagnosis of tumors in the upper respiratory tract, bronchi, digestive tract, liver, gallbladder, and pancreatic lumens.
The product, which includes a disposable ultrasound probe for endoscopes and ultrasound diagnostic equipment for endoscopes, comprises key functional modules such as the main unit, probe driver, and fiber-type ultrasound probe for disposable endoscopes. It also features auxiliary modules like a display screen, control panel, foot switch, and trolley, enhancing its usability in medical settings.- Flcube.com
