
Jpi America, Inc.
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AJEX 9015/135H PORTABLE X-RAY is an FDA 510(k)-cleared medical device (K052341) manufactured by Jpi America, 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 October 6, 2005. Regulation: 8.