Calcium Scoring
by Siemens Medical Solutions USA, Inc.
510(k) K990426
Calcium Scoring is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K990426 on 12 May 1999, 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 | NumberK990426 | Date12 May 1999 | StatusActive |
Official records
- FDA 510(k) database K990426
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- Withdrawn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 K990426
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 CaScoring 10561487 | 10561487 | 04056869007786 | On the market | |
| syngo.CT CaScoring 11060592 | 11060592 | 04056869013879 | On the market | |
| syngo.CT CaScoring 11060621 | 11060621 | 04056869026343 | On the market |
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