BIOPSY HANDY, MRI BIOPSY HANDY

BIOPSY HANDY, MRI BIOPSY HANDY is an FDA 510(k)-cleared medical device (K102771) manufactured by Somatex Medical Technologies GmbH. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 23, 2011. Regulation: 8.