
Source-Ray, Inc.
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OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115 is an FDA 510(k)-cleared medical device (K062472) manufactured by Source-Ray, 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 30, 2006. Regulation: 8.