dS Sentinelle Breast 16ch 1.5T Coil

dS Sentinelle Breast 16ch 1.5T Coil is an FDA 510(k)-cleared medical device (K213735) manufactured by Invivo Corporation (Business Trade Name: Philips). This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 7, 2022. Regulation: 8.