syngo. CT Extended Functionalities
by Siemens Medical Solutions USA, Inc.
510(k) K203699
syngo. CT Extended Functionalities is a medical device (FDA Class II; FDA product code JAK, System, X-Ray, Tomography, Computed) made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K203699 on 30 Apr 2021, 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 | NumberK203699 | Date30 Apr 2021 | StatusActive |
Official records
- FDA 510(k) database K203699
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JAK
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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