syngo.Interventional 11327988
syngo.Interventional 11327988 is a basic x-ray clinical assessment support software (FDA Class II; FDA product code LLZ, System, image processing, radiological) made by Siemens Healthcare GmbH, cleared under FDA 510(k) K190780 on 12 Sep 2019 and listed in FDA GUDID since 13 Jan 2020 (UDI-DI 04056869248653), active as of 12 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04056869248653 | Date13 Jan 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190780 | Date12 Sep 2019 | StatusActive |
Official records
- AccessGUDID record 04056869248653
- FDA 510(k) database K190780
Across registries
- FDA 510(k) K190780 decided 12 Sep 2019 Active
- FDA GUDID UDI-DI 04056869248653 listed 13 Jan 2020 Listed
Timeline
- Cleared FDA 510(k) K190780
- Listed FDA GUDID 04056869248653
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- syngo.Interventional
- Generic name
- Basic x-ray clinical assessment support software
- Model / reference
- 11327988
- Primary DI / UDI-DI
- 04056869248653
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Basic x-ray clinical assessment support software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution