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FDA 510(k)

Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T

K-Number: K160618 · 2016-06-09

ApplicantGe Medical Systems, LLC
Decision Date2016-06-09
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2016-06-09 under approval number K160618. 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 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T?

Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T is a medical device that received FDA 510(k) clearance on 2016-06-09. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K160618.

When was Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T approved by the FDA?

Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T received FDA 510(k) clearance on 2016-06-09, under approval number K160618.

What company makes Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T?

Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T is manufactured by Ge Medical Systems, LLC.

What is the FDA product code for Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T?

The FDA product code for Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T is 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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