SYNGO NEURO PBV-IR

SYNGO NEURO PBV-IR is an FDA 510(k)-cleared medical device (K111052) 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 May 19, 2011. Regulation: 8.