
Transamerican Medical Imaging
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SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM is an FDA 510(k)-cleared medical device (K092713) manufactured by Transamerican Medical Imaging. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 15, 2010. Regulation: 8.