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FDA 510(k)

MAGNETIC RESONANCE DIAGNOSTIC SYSTEM

K-Number: K980114 · 1998-03-30

Decision Date1998-03-30
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNETIC RESONANCE DIAGNOSTIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 1998-03-30 under 510(k) number K980114. 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 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM?

MAGNETIC RESONANCE DIAGNOSTIC SYSTEM is a medical device that received FDA 510(k) clearance on 1998-03-30. The listed applicant is GE Medical Systems. The 510(k) number is K980114.

When did MAGNETIC RESONANCE DIAGNOSTIC SYSTEM receive FDA 510(k) clearance?

MAGNETIC RESONANCE DIAGNOSTIC SYSTEM received FDA 510(k) clearance on 1998-03-30, under 510(k) number K980114.

Who is the listed applicant for MAGNETIC RESONANCE DIAGNOSTIC SYSTEM?

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

What is the FDA product code for MAGNETIC RESONANCE DIAGNOSTIC SYSTEM?

The FDA product code for MAGNETIC RESONANCE DIAGNOSTIC SYSTEM 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.

Other records listing GE Medical Systems 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.

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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.

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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