syngo.CT Brain Quantification
by Siemens Medical Solutions USA, Inc.
510(k) K260055
syngo.CT Brain Quantification is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K260055 on 25 Sep 2026, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK260055 | Date25 Sep 2026 | StatusActive |
Official records
- FDA 510(k) database K260055
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QIH
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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