COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION

COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION is an FDA 510(k)-cleared medical device (K993517) manufactured by Medison America, 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 November 1, 1999. Regulation: 8.