FlexView Diagnostic (v1.1.20)

FlexView Diagnostic (v1.1.20) is an FDA 510(k)-cleared medical device (K233226) manufactured by Radical Imaging, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 16, 2024. Regulation: 8.