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FDA 510(k)

MR VESSELLQ XPRESS

K-Number: K122164 · 2012-09-07

ApplicantGE Medical Systems SCS
Decision Date2012-09-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MR VESSELLQ XPRESS is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems SCS. It received FDA 510(k) clearance on 2012-09-07 under 510(k) number K122164. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MR VESSELLQ XPRESS?

MR VESSELLQ XPRESS is a medical device that received FDA 510(k) clearance on 2012-09-07. The listed applicant is GE Medical Systems SCS. The 510(k) number is K122164.

When did MR VESSELLQ XPRESS receive FDA 510(k) clearance?

MR VESSELLQ XPRESS received FDA 510(k) clearance on 2012-09-07, under 510(k) number K122164.

Who is the listed applicant for MR VESSELLQ XPRESS?

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

What is the FDA product code for MR VESSELLQ XPRESS?

The FDA product code for MR VESSELLQ XPRESS is LLZ.

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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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