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Philips Medical Systems Nederland B.V.
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ACHIEVA 1.5T & INERA 1.5T FAMILY is an FDA 510(k)-cleared medical device (K052013) manufactured by Philips Medical Systems Nederland B.V.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 1, 2005. Regulation: 8.