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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

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.

See Also:

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

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.