SIEMENS PHO/SONIC ALPHA 1000

SIEMENS PHO/SONIC ALPHA 1000 is an FDA 510(k)-cleared medical device (K802759) manufactured by Siemens Gammasonics, 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 January 6, 1981. Regulation: 8.