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FDA 510(k)

GE SIGNA 3.0T WITH EXCITE MR SYSTEM

K-Number: K040444 · 2004-04-14

ApplicantGeneral Electric Co.
Decision Date2004-04-14
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE SIGNA 3.0T WITH EXCITE MR 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 2004-04-14 under 510(k) number K040444. 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 GE SIGNA 3.0T WITH EXCITE MR SYSTEM?

GE SIGNA 3.0T WITH EXCITE MR SYSTEM is a medical device that received FDA 510(k) clearance on 2004-04-14. The listed applicant is General Electric Co.. The 510(k) number is K040444.

When did GE SIGNA 3.0T WITH EXCITE MR SYSTEM receive FDA 510(k) clearance?

GE SIGNA 3.0T WITH EXCITE MR SYSTEM received FDA 510(k) clearance on 2004-04-14, under 510(k) number K040444.

Who is the listed applicant for GE SIGNA 3.0T WITH EXCITE MR 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 GE SIGNA 3.0T WITH EXCITE MR SYSTEM?

The FDA product code for GE SIGNA 3.0T WITH EXCITE MR 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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