Cleared Traditional

K122164 - MR VESSELLQ XPRESS (FDA 510(k) Clearance)

K122164 · GE Medical Systems SCS · Radiology device

Sep 2012

Decision

49d

Days

Class 2

Risk

K122164 is an FDA 510(k) clearance for the MR VESSELLQ XPRESS. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by GE Medical Systems SCS (Waukesha, US). The FDA issued a Cleared decision on September 7, 2012, 49 days after receiving the submission on July 20, 2012.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K122164 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 20, 2012
Decision Date	September 07, 2012
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF