
Sigma Biomedics, Inc.
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BIO-RAY SDX DIGITAL X-RAY SYSTEM is an FDA 510(k)-cleared medical device (K060179) manufactured by Sigma Biomedics, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 7, 2006. Regulation: 8.