NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory is an FDA 510(k)-cleared medical device (K143678) 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 February 5, 2015. Regulation: 8.