ECHELON Synergy— 510(k) K262902
Substantially EquivalentFujifilm Corporation
FDA 510(k) clearance K262902 for ECHELON Synergy, Substantially Equivalent on 2026-10-09. Applicant: Fujifilm Corporation. Device class: 2.
Summary
ECHELON Synergy is an MRI system from Fujifilm, filed under LNH, nuclear magnetic resonance imaging systems. The record doesn't give field strength or configuration details.
Class II, 21 CFR 892.1000. The Radiology panel reviewed it as a Traditional 510(k).
Fujifilm filed from Minato-ku, Japan. Review took 52 days (August 18 to October 9, 2026).
Clearance details
- Applicant
- Fujifilm Corporation
- Product code
- Product code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minato-Ku, JP
Recent devices under product code LNH
view allMore clearances from Fujifilm Corporation
view allAdverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.