ECHELON Synergy
by Fujifilm Corporation 2 variants
510(k) K251386
ECHELON Synergy is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K251386 on 17 Sep 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 | NumberK251386 | Date17 Sep 2025 | StatusActive |
Official records
- FDA 510(k) database K251386
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LNH
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1000
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K251386
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 | |||
|---|---|---|---|---|
| ECHELON Synergy MR-TSP-156B | ECHELON Synergy Spine Coil B / MR-TSP-156B | 04547410565195 | — | On the market |
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