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Standard Imaging, Inc.
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MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER is an FDA 510(k)-cleared medical device (K002833) manufactured by Standard 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 September 27, 2000. Regulation: 8.