iLab Polaris Multi-Modality Guidance System

iLab Polaris Multi-Modality Guidance System is an FDA 510(k)-cleared medical device (K201178) manufactured by Boston Scientific. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 28, 2020. Regulation: 8.