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Image-Guided Neurologics, Inc.
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NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX is an FDA 510(k)-cleared medical device (K031885) manufactured by Image-Guided Neurologics, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 20, 2003. Regulation: 8.