
Iterative Scopes, Inc.
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SKOUT Software is an FDA 510(k)-cleared medical device (K213686) manufactured by Iterative Scopes, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 11, 2022. Regulation: 8.