2000 X-RAY - TOMOGRAPHIC

2000 X-RAY - TOMOGRAPHIC is an FDA 510(k)-cleared medical device (K931815) manufactured by Imaging Sciences 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, 1993. Regulation: 8.