RADIANCE ULTRA 32 4K ZEROWIRE DUO

RADIANCE ULTRA 32 4K ZEROWIRE DUO is an FDA 510(k)-cleared medical device (K222890) manufactured by Nds Surgical Imaging, LLC. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 18, 2022. Regulation: 8.