Biograph Trinion
by Siemens Medical Solutions USA, Inc.
510(k) K251561
Biograph Trinion is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K251561 on 31 Jul 2025, 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 | NumberK251561 | Date31 Jul 2025 | StatusActive |
Official records
- FDA 510(k) database K251561
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KPS
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1200
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K251561
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 | |||
|---|---|---|---|---|
| Biograph Trinion EP CT128 10756478 | 10756478 | 04056869961088 | On the market | |
| Biograph Trinion EP CT64 10756474 | 10756474 | 04056869961064 | On the market | |
| Biograph Trinion EP2 CT128 10756479 | 10756479 | 04056869961095 | On the market | |
| Biograph Trinion EP2 CT64 10756476 | 10756476 | 04056869961071 | On the market | |
| Biograph Trinion.X EP5 CT128 11713856 | 11713856 | 04068151048056 | On the market | |
| Biograph Trinion.X EP5 CT64 11713854 | 11713854 | 04068151048087 | On the market | |
| Biograph Trinion.X EP9 CT128 11713858 | 11713858 | 04068151048063 | On the market | |
| Biograph Trinion.X EP9 CT64 11713857 | 11713857 | 04068151048070 | On the market |
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