syngo Application Software (VE21)
by Siemens Medical Solution USA, Inc.
510(k) K220433
syngo Application Software (VE21) is a Class II device made by Siemens Medical Solution USA, Inc., cleared under FDA 510(k) K220433 on 16 Aug 2022, 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 | NumberK220433 | Date16 Aug 2022 | StatusActive |
Official records
- FDA 510(k) database K220433
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- Withdrawn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 K220433
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 11327667 | 11327667 | 04056869124162 | — | On the market |