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Ann Arbor Digital Devices
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INSTANT-X, MODELS 1713 & 128 is an FDA 510(k)-cleared medical device (K042791) manufactured by Ann Arbor Digital Devices. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 30, 2005. Regulation: 8.