
Esaote, S.p.A.
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MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100 is an FDA 510(k)-cleared medical device (K060827) manufactured by Esaote, S.p.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 May 18, 2006. Regulation: 8.