syngo Application Software
by Siemens Medical Solution USA, Inc. 2 variants
510(k) K190780
syngo Application Software is a Class II device made by Siemens Medical Solution USA, Inc., cleared under FDA 510(k) K190780 on 12 Sep 2019, 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 | NumberK190780 | Date12 Sep 2019 | StatusActive |
Official records
- FDA 510(k) database K190780
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- Withdrawn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 K190780
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 |
| syngo.Interventional 11327988 | 11327988 | 04056869248653 | — | On the market |