
Image Analysis, Inc.
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N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX is an FDA 510(k)-cleared medical device (K040782) manufactured by Image Analysis, 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 July 12, 2004. Regulation: 8.