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FDA 510(k)

GEM OPTION FOR 1.5 MRI SYSTEMS

K-Number: K103335 · 2011-03-07

ApplicantGE Healthcare
Decision Date2011-03-07
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GEM OPTION FOR 1.5 MRI SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2011-03-07 under 510(k) number K103335. 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 GEM OPTION FOR 1.5 MRI SYSTEMS?

GEM OPTION FOR 1.5 MRI SYSTEMS is a medical device that received FDA 510(k) clearance on 2011-03-07. The listed applicant is GE Healthcare. The 510(k) number is K103335.

When did GEM OPTION FOR 1.5 MRI SYSTEMS receive FDA 510(k) clearance?

GEM OPTION FOR 1.5 MRI SYSTEMS received FDA 510(k) clearance on 2011-03-07, under 510(k) number K103335.

Who is the listed applicant for GEM OPTION FOR 1.5 MRI SYSTEMS?

The FDA 510(k) record lists GE Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEM OPTION FOR 1.5 MRI SYSTEMS?

The FDA product code for GEM OPTION FOR 1.5 MRI SYSTEMS is MOS.

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Other records listing GE Healthcare as applicant

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Related Devices (Code: MOS)

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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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