RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0

RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0 is an FDA 510(k)-cleared medical device (K002240) manufactured by Precision Therapy Intl., 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 August 22, 2000. Regulation: 8.