Voluson P6 and Voluson P8

Voluson P6 and Voluson P8 is an FDA 510(k)-cleared medical device (K180535) manufactured by GE Healthcare. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 28, 2018. Regulation: 8.