
Fluoro Scan Imaging Systems, Inc.
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FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS is an FDA 510(k)-cleared medical device (K002198) manufactured by Fluoro Scan Imaging Systems, 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 16, 2000. Regulation: 8.