iLab Polaris Multi-Modality Guidance System

iLab Polaris Multi-Modality Guidance System is an FDA 510(k)-cleared medical device (K210889) manufactured by Boston Scientific Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 24, 2021. Regulation: 8.