NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

Reason: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

Code information: Material Number: 11549431; UDI-DI: 04056869978741; Serial Numbers: 183047, 183051, 183048, 183050, 183046;

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.