SonoScape Receives FDA’s 510(k) Clearance for its HD-550 Endoscopy System

SonoScape has been granted the FDA’s 510(k) clearance for its flagship video endoscopy system, HD-550, for gastrointestinal diagnosis.

The device is meant to be paired with a four-LED light source, which supports high-definition imaging, according to the Shenzhen, China-based company.

The imaging technology enhances vascular and mucosal color contrast, which reveals more details of the GI tract, enabling doctors to characterize lesions, the company said.