SonoScape today announced that it received FDA 510(k) clearance for its video endoscopy system HD-550 for gastrointestinal diagnosis.
The HD-550 endoscopy system has a 4-LED light source that supports high definition imaging with multi-spectrum and multi-mode. Its varying light modes enhance vascular and mucosal color contrast to reveal more details in the GI tract.
China-based SonoScape designed the 550 series videoscope to help doctors in detection, demarcation and characterization of the lesions. It has been available outside of the U.S. since 2019, according to the company.
“We have grown into a trusted name in the global endoscopy industry, we are now ready to extend our offerings to the USA healthcare providers.” Steven He, sales director of SonoScape Endoscopy said in a news release. “This FDA clearance opens up opportunities in one of the world’s biggest endoscopy markets, indeed is a powerful boost of our brand recognition, and a tremendously important phase of business development in SonoScape’s 20 years’ history.”