Cleared Traditional

Stereo 3D option for Vision Applications

K152352 · GE Medical Systems SCS · Radiology

Jan 2016

Decision

153d

Days

Class 2

Risk

About This 510(k) Submission

K152352 is an FDA 510(k) clearance for the Stereo 3D option for Vision Applications, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on January 20, 2016, 153 days after receiving the submission on August 20, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K152352 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 20, 2015
Decision Date	January 20, 2016
Days to Decision	153 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF