ECHELON Synergy MRI system— 510(k) K223426

Name: FDA 510(k) clearance K223426
Creator: U.S. Food and Drug Administration
Published: 2023-07-13

Substantially Equivalent

Fujifilm Healthcare Corporation

FDA 510(k) clearance K223426 for ECHELON Synergy MRI system, Substantially Equivalent on 2023-07-13. Applicant: Fujifilm Healthcare Corporation. Device class: 2.

Clearance details

Applicant: Fujifilm Healthcare Corporation
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2022-11-14
Decision date: 2023-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kashiwa-Shi, JP

Download summary PDF View on FDA.gov ↗

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K261331 — I-Genius (100019400)2026-07-31

More clearances from Fujifilm Healthcare Corporation

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K241429 — ECHELON Synergy MRI System2024-08-13
K240571 — OASIS MRI System2024-04-12
K221619 — ECHELON Oval V6.2 MRI System2023-01-26
K213829 — SCENARIA View2022-05-23
K220295 — ARIETTA 502022-04-29

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.