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Quantel Medical S.A.
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AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K102027) manufactured by Quantel Medical S.A.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 2010. Regulation: 8.