Cleared Traditional

K152352 - Stereo 3D option for Vision Applications (FDA 510(k) Clearance)

K152352 · GE Medical Systems SCS · Radiology device

Jan 2016

Decision

153d

Days

Class 2

Risk

K152352 is an FDA 510(k) clearance for the Stereo 3D option for Vision Applications. This device is classified as 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 FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K152352 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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