
American Medical Sales, Inc.
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CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0 is an FDA 510(k)-cleared medical device (K052537) manufactured by American Medical Sales, 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 November 15, 2005. Regulation: 8.