Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter

Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter is an FDA 510(k)-cleared medical device (K230620) manufactured by Gentuity, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 7, 2023. Regulation: 8.