TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.)

TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.) is an FDA 510(k)-cleared medical device (K993038) manufactured by Toshiba America Medical Systems, In.C. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 6, 1999. Regulation: 8.