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FDA 510(k)

GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM

K-Number: K052293 · 2005-09-21

ApplicantGe Medical Systems, LLC
Decision Date2005-09-21
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM 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 2005-09-21 under 510(k) number K052293. 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 1.5T AND 3.0T SIGNA HDX MR SYSTEM?

GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM is a medical device that received FDA 510(k) clearance on 2005-09-21. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K052293.

When did GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM receive FDA 510(k) clearance?

GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM received FDA 510(k) clearance on 2005-09-21, under 510(k) number K052293.

Who is the listed applicant for GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM?

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 GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM?

The FDA product code for GE 1.5T AND 3.0T SIGNA HDX 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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