syngo Application Software
by Siemens Medical Solutions USA, Inc. 6 variants
510(k) K230955
syngo Application Software is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K230955 on 20 Dec 2023, 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 | NumberK230955 | Date20 Dec 2023 | StatusActive |
Official records
- FDA 510(k) database K230955
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K230955
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| syngo Application Software 30000266 | 30000266 | 04056869964546 | — | On the market |