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FDA 510(k)

OPTIMA MR450W

K-Number: K123522 · 2013-03-13

ApplicantGe Healthcare (Ge Medical Systems, LLC)
Decision Date2013-03-13
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPTIMA MR450W is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare (Ge Medical Systems, LLC). It received FDA 510(k) clearance on 2013-03-13 under 510(k) number K123522. 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 OPTIMA MR450W?

OPTIMA MR450W is a medical device that received FDA 510(k) clearance on 2013-03-13. The listed applicant is Ge Healthcare (Ge Medical Systems, LLC). The 510(k) number is K123522.

When did OPTIMA MR450W receive FDA 510(k) clearance?

OPTIMA MR450W received FDA 510(k) clearance on 2013-03-13, under 510(k) number K123522.

Who is the listed applicant for OPTIMA MR450W?

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

What is the FDA product code for OPTIMA MR450W?

The FDA product code for OPTIMA MR450W is LNH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Ge Healthcare (Ge Medical Systems, LLC) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213668SIGNA HeroK202966SIGNA ArchitectK193282SIGNA PremierK132376DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T

Related Devices (Code: LNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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