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FDA 510(k)

1.5T OPTIMA MR430S

K-Number: K103238 · 2011-02-11

ApplicantGe Medical Systems, LLC
Decision Date2011-02-11
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

1.5T OPTIMA MR430S is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2011-02-11 under 510(k) number K103238. 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 1.5T OPTIMA MR430S?

1.5T OPTIMA MR430S is a medical device that received FDA 510(k) clearance on 2011-02-11. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K103238.

When did 1.5T OPTIMA MR430S receive FDA 510(k) clearance?

1.5T OPTIMA MR430S received FDA 510(k) clearance on 2011-02-11, under 510(k) number K103238.

Who is the listed applicant for 1.5T OPTIMA MR430S?

The FDA 510(k) record lists Ge Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 1.5T OPTIMA MR430S?

The FDA product code for 1.5T OPTIMA MR430S 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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