Chinese endoscopy systems maker SonoScape announced that its HD-550 Endoscopy system has received 510(k) clearance from the US Food and Drug Administration (FDA).

The device, the latest addition to the firm’s Endoscopic product portfolio, is intended for the diagnosis of gastrointestinal problems.

The HD-550 endoscopic equipment has a 4-LED light source that supports 1080P high definition imaging with multi-spectrum and multi-mode.

Equipped with chromoendoscopy SFI (Spectral Focused Imaging) and VIST (Versatile Intelligent Staining Technology) light modes, the device increases vascular and mucosal colour contrast to reveal more details in the GI tract.

SonoScape has made the HD-550 endoscopy system to aid clinicians in easy detection, demarcation, and characterisation of the lesions.

The clearance includes the 550 series videoscopes, whose mobility has been approved by prominent endoscopists worldwide.

Since 2019, the HD-550 endoscopic system is commercially available outside of the US.

By 2021, the HD-550 endoscopic system has been installed in nearly 40 countries due to its advanced features, quality and versatility.

SonoScape endoscopy sales director Steven He said: “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.

“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.”

Founded in 2002, SonoScape offers ultrasound and endoscopy solutions’ sales and services in over 130 countries, providing local hospitals and clinicians with full imaging diagnostic evidence and technical assistance.

In July last year, SonoScape secured CE mark approval for its linear-array echoendoscope called EG-UC5T to conduct various therapeutic interventional endoscopic procedures under sonographic guidance.