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Hopkins Imaging Systems, Inc.
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MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K000630) manufactured by Hopkins Imaging Systems, 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 May 11, 2000. Regulation: 8.