Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit

Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit is an FDA 510(k)-cleared medical device (K202014) manufactured by Siemens Medical Solutions USA, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 7, 2020. Regulation: 8.