Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software

Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software is an FDA 510(k)-cleared medical device (K162503) manufactured by Cardiac Insight, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 23, 2017. Regulation: 8.