FDA-Device2026-02-11Class II
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Siemens Medical Solutions USA, Inc
Hazard
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
Affected count
2 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1239-2026Original summary
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. Material Number: 11330002; UDI-DI: 04056869231051; Serial Numbers: 125205, 125250; Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel. Affected quantity: 2 units
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