
Philips Health Care
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ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T is an FDA 510(k)-cleared medical device (K110151) manufactured by Philips Health Care. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 21, 2011. Regulation: 8.