
Ninepoint Medical, Inc.
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NVISION VLE IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K120800) manufactured by Ninepoint Medical, 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 April 24, 2013. Regulation: 8.

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