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FDA 510(k)

ECHELON Synergy MRI System

K-Number: K241429 · 2024-08-13

ApplicantFujifilm Healthcare Corporation
Decision Date2024-08-13
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECHELON Synergy MRI System is a medical device manufactured by Fujifilm Healthcare Corporation. It received FDA 510(k) clearance on 2024-08-13 under approval number K241429. 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 MRI System?

ECHELON Synergy MRI System is a medical device that received FDA 510(k) clearance on 2024-08-13. It is manufactured by Fujifilm Healthcare Corporation. The 510(k) number is K241429.

When was ECHELON Synergy MRI System approved by the FDA?

ECHELON Synergy MRI System received FDA 510(k) clearance on 2024-08-13, under approval number K241429.

What company makes ECHELON Synergy MRI System?

ECHELON Synergy MRI System is manufactured by Fujifilm Healthcare Corporation.

What is the FDA product code for ECHELON Synergy MRI System?

The FDA product code for ECHELON Synergy MRI System is LNH.

Related Clinical Trials

NCT03736226 A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China ACTIVE_NOT_RECRUITING NCT05305430 Real World Data Collection on the Synergy Cervical Disc RECRUITING NCT05880823 Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc WITHDRAWN NCT06383962 Post-Market Data Collection to Evaluate the Performance of the Synergy Disc® RECRUITING NCT05417893 Non-inferiority Clinical Trial to Compare the Safety and Performance of MeRes100 Sirolimus-eluting BioResorbable Vascular Scaffold System Versus Contemporary DES Platforms in Patients With de Novo Coronary Artery Lesions WITHDRAWN

Other Devices by Fujifilm Healthcare Corporation

K213829SCENARIA View K220295ARIETTA 50 K223426ECHELON Synergy MRI system K221619ECHELON Oval V6.2 MRI System K240571OASIS MRI System

Related Devices (Code: 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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