Device product
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Z-1242-2026
Product summary
- Event
- Event 98206
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-1242-2026
Official wording
Reason: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Code information: Material Number: 10191100; UDI-DI: 04068151014655; Serial Numbers: 258043, 258055;
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
Derived failure modes
-
Unknown
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.