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FDA 510(k)

MAGiC

K-Number: K161397 · 2016-08-31

ApplicantGe Medical Systems, LLC
Decision Date2016-08-31
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGiC is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2016-08-31 under approval number K161397. 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 MAGiC?

MAGiC is a medical device that received FDA 510(k) clearance on 2016-08-31. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K161397.

When was MAGiC approved by the FDA?

MAGiC received FDA 510(k) clearance on 2016-08-31, under approval number K161397.

What company makes MAGiC?

MAGiC is manufactured by Ge Medical Systems, LLC.

What is the FDA product code for MAGiC?

The FDA product code for MAGiC is LNH.

Other Devices by Ge Medical Systems, LLC

K163213Revolution CT K162403HyperBand K162990Optima XR240amx K161574Discovery MI K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T K171128SIGNA Premier

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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

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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