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FDA 510(k)

GE SIGNA MR ONCOLOGY PACKAGE

K-Number: K081916 · 2008-07-22

ApplicantGe Medical Systems, LLC
Decision Date2008-07-22
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE SIGNA MR ONCOLOGY PACKAGE 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 2008-07-22 under 510(k) number K081916. 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 MR ONCOLOGY PACKAGE?

GE SIGNA MR ONCOLOGY PACKAGE is a medical device that received FDA 510(k) clearance on 2008-07-22. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K081916.

When did GE SIGNA MR ONCOLOGY PACKAGE receive FDA 510(k) clearance?

GE SIGNA MR ONCOLOGY PACKAGE received FDA 510(k) clearance on 2008-07-22, under 510(k) number K081916.

Who is the listed applicant for GE SIGNA MR ONCOLOGY PACKAGE?

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 SIGNA MR ONCOLOGY PACKAGE?

The FDA product code for GE SIGNA MR ONCOLOGY PACKAGE 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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