
Prism Clinical Imaging, Inc.
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PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5) is an FDA 510(k)-cleared medical device (K082964) manufactured by Prism Clinical Imaging, 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 March 8, 2009. Regulation: 8.