Syngo, CT Cardiac Function
by Siemens Medical Solutions USA, Inc.
510(k) K123585
Syngo, CT Cardiac Function is a medical device (FDA Class II; FDA product code JAK, System, X-Ray, Tomography, Computed) made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K123585 on 20 Dec 2012, 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 | NumberK123585 | Date20 Dec 2012 | StatusActive |
Official records
- FDA 510(k) database K123585
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JAK
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K123585
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. CT Cardiac Function 10561486 | 10561486 | 04056869007779 | On the market | |
| syngo.CT Cardiac Function 11060595 | 11060595 | 04056869013862 | On the market | |
| syngo.CT Cardiac Function 11060624 | 11060624 | 04056869026336 | On the market |
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