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FDA 510(k)

ECHELON Synergy V10.0

K-Number: K233687 · 2024-05-03

ApplicantFUJIFILM Healthcare Americas Corporation
Decision Date2024-05-03
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECHELON Synergy V10.0 is a medical device manufactured by FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2024-05-03 under approval number K233687. 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 V10.0?

ECHELON Synergy V10.0 is a medical device that received FDA 510(k) clearance on 2024-05-03. It is manufactured by FUJIFILM Healthcare Americas Corporation. The 510(k) number is K233687.

When was ECHELON Synergy V10.0 approved by the FDA?

ECHELON Synergy V10.0 received FDA 510(k) clearance on 2024-05-03, under approval number K233687.

What company makes ECHELON Synergy V10.0?

ECHELON Synergy V10.0 is manufactured by FUJIFILM Healthcare Americas Corporation.

What is the FDA product code for ECHELON Synergy V10.0?

The FDA product code for ECHELON Synergy V10.0 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.

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