
Philips Medical Systems (Cleveland), Inc.
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MX8000 V5.0 CT SYSTEM is an FDA 510(k)-cleared medical device (K010817) manufactured by Philips Medical Systems (Cleveland), 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 June 14, 2001. Regulation: 8.