NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System is an FDA 510(k)-cleared medical device (K182616) manufactured by Ninepoint Medical, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 1, 2018. Regulation: 8.