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April 18, 2022

FDA grants 510(k) clearance for SonoScape’s endoscopy system

The HD-550 endoscopy system allows to capture and record images and videos, as well as access patient data.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to SonoScape’s HD-550 endoscopy system for gastrointestinal diagnosis.

The video endoscopy system is paired with a 4-LED light source that supports 1080P high definition and enables multi-mode as well as multi-spectrum.

It allows to capture and record images and videos and access patient data for creating and editing reports without the need of any extra software.

The HD-550 includes chromoendoscopy versatile intelligent staining technology (VIST) and spectral focused imaging (SFI) light modes which enhance vascular and mucosal colour contrast that adds to the white-light mode.

SonoScape stated that the system helps in revealing more details in the gastrointestinal tract that helps doctors to detect, demarcate, and characterise lesions.

The regulatory clearance for the video endoscopy system includes 550 series videoscopes.

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.”

Since 2019, the endoscopy system has been available outside the US and the HD550 was installed in approximately 40 countries globally.

In November last year, the company launched the linear echoendoscope EG-UC5T, the latest addition to its endoscopy product line.

The EG-UC5T is designed to provide maximum comfort in procedures and minimum concern of safety.

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