PX-100 PORTABLE X-RAY GENERATOR

PX-100 PORTABLE X-RAY GENERATOR is an FDA 510(k)-cleared medical device (K921116) manufactured by Acoma Medical Imaging, 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 October 4, 1992. Regulation: 8.