TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915

TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915 is an FDA 510(k)-cleared medical device (K022565) manufactured by Stereotaxis, 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 7, 2002. Regulation: 8.