Aquarius 8600 Digital Radiography Sensor

Aquarius 8600 Digital Radiography Sensor is an FDA 510(k)-cleared medical device (K181565) manufactured by Biokinemetrics, 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 July 12, 2018. Regulation: 8.