PUREIMAGE ULTRASOUND TRANSMISSION GEL

PUREIMAGE ULTRASOUND TRANSMISSION GEL is an FDA 510(k)-cleared medical device (K120156) manufactured by Medline. 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 7, 2012. Regulation: 8.