ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION

ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION is an FDA 510(k)-cleared medical device (K991805) manufactured by Acuson Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 1, 1999. Regulation: 8.