MAMMOVISTA B.smart (VB70)

MAMMOVISTA B.smart (VB70) is an FDA 510(k)-cleared medical device (K223363) 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 January 11, 2023. Regulation: 8.