FDA 510(k)

Trillium Oval V 5.1 MRI System

K-Number: K160152 · 2016-05-20

ApplicantHitachi Medical Systems America, Inc.

Decision Date2016-05-20

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Trillium Oval V 5.1 MRI System is a medical device manufactured by Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2016-05-20 under approval number K160152. 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 Trillium Oval V 5.1 MRI System?

Trillium Oval V 5.1 MRI System is a medical device that received FDA 510(k) clearance on 2016-05-20. It is manufactured by Hitachi Medical Systems America, Inc.. The 510(k) number is K160152.

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

Trillium Oval V 5.1 MRI System received FDA 510(k) clearance on 2016-05-20, under approval number K160152.

What company makes Trillium Oval V 5.1 MRI System?

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

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

The FDA product code for Trillium 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 K153547ECHELON 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.