FDA 510(k)

TRILLIUM Oval Head Coil 32

K-Number: K162079 · 2016-09-16

ApplicantHitachi Medical Systems America, Inc.

Decision Date2016-09-16

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TRILLIUM Oval Head Coil 32 is a medical device manufactured by Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2016-09-16 under approval number K162079. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRILLIUM Oval Head Coil 32?

TRILLIUM Oval Head Coil 32 is a medical device that received FDA 510(k) clearance on 2016-09-16. It is manufactured by Hitachi Medical Systems America, Inc.. The 510(k) number is K162079.

When was TRILLIUM Oval Head Coil 32 approved by the FDA?

TRILLIUM Oval Head Coil 32 received FDA 510(k) clearance on 2016-09-16, under approval number K162079.

What company makes TRILLIUM Oval Head Coil 32?

TRILLIUM Oval Head Coil 32 is manufactured by Hitachi Medical Systems America, Inc..

What is the FDA product code for TRILLIUM Oval Head Coil 32?

The FDA product code for TRILLIUM Oval Head Coil 32 is MOS.

Other Devices by Hitachi Medical Systems America, Inc.

K161748SUPRIA w/guideShot Option K160152Trillium Oval V 5.1 MRI System K153547ECHELON Oval V 5.1 MRI System K163528HITACHI Supria Whole-body X-ray CT System Phase 3

Related Devices (Code: MOS)

K16262316ch T/R Hand Wrist CoilQuality Electrodynamics, LLC K162966TxRx Knee 15 Flare MR Coil 1.5TQuality Electrodynamics, LLC K163066TxRx Knee 15 Flare MR Coil 3.0TQuality Electrodynamics, LLC K162863dS Small Extremity 16CH 1.5T CoilInvivo Therapeutics Corporation K16202916ch T/R Knee CoilQuality Electrodynamics, LLC K162177dS FootAnkle I6CH 1.5T CoilInvivo Corporation

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.