Cleared Traditional

GE VEO RECONSTRUCTION OPTION

K103489 · General Electric Co. · Radiology
Sep 2011
Decision
287d
Days
Class 2
Risk

About This 510(k) Submission

K103489 is an FDA 510(k) clearance for the GE VEO RECONSTRUCTION OPTION, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by General Electric Co. (Waukesha, US). The FDA issued a Cleared decision on September 9, 2011, 287 days after receiving the submission on November 26, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K103489 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 2010
Decision Date September 09, 2011
Days to Decision 287 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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