ECHELON Synergy
FDA 510(k) K251386 · Fujifilm Corporation
510(k) numberK251386
Submission
- Device name
- ECHELON Synergy
- Applicant
- Fujifilm Corporation
Minato-Ku, JP - Received
- May 5, 2025
- Decision date
- September 17, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LNH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260758 | MAGNETOM Free.Max; MAGNETOM Free.StarLNH · Traditional | Siemens Shenzhen Magnetic Resonance , Ltd. | 09/01/2026SE |
| K262622 | Swoop® Portable MR Imaging® SystemLNH · Special | Hyperfine, Inc. | 08/19/2026SE |
| K254250 | MagicScan-1.5, GreenMR Serenity 1.5TLNH · Traditional | Xingaoyi Medical Equipment Co.,Ltd | 08/17/2026SE |
| K253808 | AIR Recon DLLNH · Traditional | GE Medical Systems | 08/13/2026SE |
| K261331 | I-Genius (100019400)LNH · Traditional | Esaote, S.p.A. | 07/31/2026SE |
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureLNH · Traditional | Siemens Healthineers AG | 07/31/2026SE |
| K260113 | uMR AstraLNH · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 05/22/2026SE |
| K253862 | APERTO Lucent MRI SystemLNH · Traditional | Fujifilm Corporation | 04/06/2026SE |
| K260746 | S-scan Open (100001800)LNH · Special | Esaote, S.p.A. | 03/27/2026SE |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for…LNH · Traditional | Canon Medical Systems Corporation | 03/27/2026SE |
More from Canon Medical Systems Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K253836 | FCT iStream Phase 2JAK · Traditional | 09/04/2026SE |
| K261170 | BA-004CCITX · Traditional | 08/12/2026SE |
| K260567 | EW10-EC02 Endoscopy Support ProgramQNP · Special | 08/07/2026SE |
| K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01FET · Special | 07/02/2026SE |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TEOQ · Traditional | 06/16/2026SE |
| K254075 | Synapse Lung Nodule AIOEB · Traditional | 05/27/2026SE |
| K254189 | Synapse 3D Base Tools (V7.2)QIH · Traditional | 04/30/2026SE |
| K253862 | APERTO Lucent MRI SystemLNH · Traditional | 04/06/2026SE |
| K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…FDT · Traditional | 03/09/2026SE |
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFDS · Traditional | 02/17/2026SE |
Questions and answers
When was ECHELON Synergy cleared by the FDA?
ECHELON Synergy (K251386) received a 510(k) decision of Substantially Equivalent on September 17, 2025, 135 days after the submission was received.
What is the product code of K251386?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.