Submission Details
| 510(k) Number | K251386 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 05, 2025 |
| Decision Date | September 17, 2025 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
ECHELON Synergy
Sep 2025
Decision
135d
Days
Class 2
Risk
About This 510(k) Submission
K251386 is an FDA 510(k) clearance for the ECHELON Synergy, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Fujifilm Corporation (Minato-Ku, JP). The FDA issued a Cleared decision on September 17, 2025, 135 days after receiving the submission on May 5, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.
Device Classification
| Product Code | LNH — System, Nuclear Magnetic Resonance Imaging |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1000 |
Manufacturer
Similar Devices — LNH System, Nuclear Magnetic Resonance Imaging
All 1093
K254277 · Aspect Imaging, Ltd.
· Mar 2026
K253413 · Perspectum, Ltd.
· Mar 2026
K251901 · Esaote, S.P.A.
· Mar 2026
K260265 · Siemens Shenzhen Magnetic Resonance , Ltd.
· Feb 2026
K253648 · Philips Medical Systems Nederland B.V.
· Feb 2026
K253780 · Ge Medical Systems, LLC
· Feb 2026
More from Fujifilm Corporation
View all
K251861
· FDT · Mar 2026
K250550
· FDS · Feb 2026
K253568
· FDS · Feb 2026
K250863
· EOQ · Dec 2025
K244017
· EOQ · Jun 2025