FDA 510(k)

ECHELON Oval V 5.1 MRI System

K-Number: K153547 · 2016-03-31

ApplicantHitachi Medical Systems America, Inc.

Decision Date2016-03-31

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ECHELON Oval V 5.1 MRI System is a medical device manufactured by Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2016-03-31 under approval number K153547. 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 Oval V 5.1 MRI System?

ECHELON Oval V 5.1 MRI System is a medical device that received FDA 510(k) clearance on 2016-03-31. It is manufactured by Hitachi Medical Systems America, Inc.. The 510(k) number is K153547.

When was ECHELON Oval V 5.1 MRI System approved by the FDA?

ECHELON Oval V 5.1 MRI System received FDA 510(k) clearance on 2016-03-31, under approval number K153547.

What company makes ECHELON Oval V 5.1 MRI System?

ECHELON Oval V 5.1 MRI System is manufactured by Hitachi Medical Systems America, Inc..

What is the FDA product code for ECHELON Oval V 5.1 MRI System?

The FDA product code for ECHELON Oval V 5.1 MRI System is LNH.

Other Devices by Hitachi Medical Systems America, Inc.

K162079TRILLIUM Oval Head Coil 32 K161748SUPRIA w/guideShot Option K160152Trillium Oval V 5.1 MRI System K163528HITACHI Supria Whole-body X-ray CT System Phase 3

Related Devices (Code: LNH)

K162940MultiBand SENSEPhilips Medical Systems Nederland B.V. K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation K162102MAGNETOM Avantofit, MAGNETOM SkyrafitSiemens Medi Cal Solutions, Inc. K162403HyperBandGe Medical Systems, LLC K161795MAGNETOM ESSENZASiemens Medical Solutions USA, Inc. K161973G-scan Brio, S-scanEsaote, S.p.A.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.