HEALTH IMAGES, INC. HI-STANDARD

HEALTH IMAGES, INC. HI-STANDARD is an FDA 510(k)-cleared medical device (K944228) manufactured by Health Images, 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 19, 1995. Regulation: 8.