INGENUITY TF PET/MR

INGENUITY TF PET/MR is an FDA 510(k)-cleared medical device (K103483) manufactured by Philips Healthcare (Cleveland). This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 22, 2011. Regulation: 8.