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Carestream Health, Inc.
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CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM is an FDA 510(k)-cleared medical device (K081836) manufactured by Carestream Health, 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 July 29, 2008. Regulation: 8.