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FDA 510(k)

SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM

K-Number: K931298 · 1994-01-18

ApplicantGeneral Electric Co.
Decision Date1994-01-18
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1994-01-18 under 510(k) number K931298. 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 SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM?

SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM is a medical device that received FDA 510(k) clearance on 1994-01-18. The listed applicant is General Electric Co.. The 510(k) number is K931298.

When did SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM receive FDA 510(k) clearance?

SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM received FDA 510(k) clearance on 1994-01-18, under 510(k) number K931298.

Who is the listed applicant for SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM?

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

What is the FDA product code for SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM?

The FDA product code for SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM 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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