syngo.CT Cardiac Function 11060595
syngo.CT Cardiac Function 11060595 is a full-body CT system (FDA Class II; FDA product code JAK, System, x-ray, tomography, computed) made by Siemens Healthcare GmbH, cleared under FDA 510(k) K123585 on 20 Dec 2012 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04056869013862), 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 | Number04056869013862 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123585 | Date20 Dec 2012 | StatusActive |
Official records
- AccessGUDID record 04056869013862
- FDA 510(k) database K123585
Across registries
- FDA 510(k) K123585 decided 20 Dec 2012 Active
- FDA GUDID UDI-DI 04056869013862 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K123585
- Listed FDA GUDID 04056869013862
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- syngo.CT Cardiac Function
- Generic name
- Full-body CT system
- Model / reference
- 11060595
- Primary DI / UDI-DI
- 04056869013862
- 510(k) Number
- FDA product code
- JAK
- GMDN term
- Full-body CT system
- Device class
- Class II
- Regulation number
- 892.1750
- GUDID distribution status
- In Commercial Distribution
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