DOT-A, DOT-AR PXP-E, PXP-ER

DOT-A, DOT-AR PXP-E, PXP-ER is an FDA 510(k)-cleared medical device (K841905) manufactured by Siemens Gammasonics, 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 8, 1984. Regulation: 8.