DIGITAL IMAGING SYSTEM (BSR)

DIGITAL IMAGING SYSTEM (BSR) is an FDA 510(k)-cleared medical device (K991922) manufactured by Siemens Medical Solutions USA, 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 31, 1999. Regulation: 8.