780 nm SPY Portable Handheld Imaging (SPY-PHI) System

780 nm SPY Portable Handheld Imaging (SPY-PHI) System is an FDA 510(k)-cleared medical device (K261037) manufactured by Stryker Endoscopy. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 27, 2026. Regulation: 8.