
Instrumentarium Imaging, Inc.
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ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 is an FDA 510(k)-cleared medical device (K973642) manufactured by Instrumentarium Imaging, 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 November 20, 1997. Regulation: 8.