Cleared Traditional

K262902 - ECHELON Synergy

K262902 is an FDA 510(k) clearance for ECHELON Synergy, manufactured by Fujifilm Corporation. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K262902 · Fujifilm Corporation · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
52d
Days
Class 2
Risk

K262902 is an FDA 510(k) clearance for the ECHELON Synergy. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Fujifilm Corporation (Minato-Ku, JP). The FDA issued a Cleared decision on October 9, 2026 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K262902

510(k) Number K262902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2026
Decision Date October 09, 2026
Days to Decision 52 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 107d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

FUJIFILM Healthcare Americas Corporation
Chaitrali Kulkarni

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 1109
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K262902 · ECHELON Synergy
Download PDF FDA Summary Fujifilm Corporation