ECHELON Synergy
K-Number: K251386 · 2025-09-17
ApplicantFujifilm Corporation
Decision Date2025-09-17
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ECHELON Synergy is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2025-09-17 under approval number K251386. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ECHELON Synergy?
ECHELON Synergy is a medical device that received FDA 510(k) clearance on 2025-09-17. It is manufactured by Fujifilm Corporation. The 510(k) number is K251386.
When was ECHELON Synergy approved by the FDA?
ECHELON Synergy received FDA 510(k) clearance on 2025-09-17, under approval number K251386.
What company makes ECHELON Synergy?
ECHELON Synergy is manufactured by Fujifilm Corporation.
What is the FDA product code for ECHELON Synergy?
The FDA product code for ECHELON Synergy is LNH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.