iMac 27 & PL 4.0

iMac 27 & PL 4.0 is an FDA 510(k)-cleared medical device (K200889) manufactured by Quantum-Spectra, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 1, 2020. Regulation: 8.