Cleared Traditional

ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION

K132944 · Ge Hungary Kft · Radiology

Mar 2014

Decision

176d

Days

Class 2

Risk

About This 510(k) Submission

K132944 is an FDA 510(k) clearance for the ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION, a System, Simulation, Radiation Therapy (Class II — Special Controls, product code KPQ), submitted by Ge Hungary Kft (Waukesha, US). The FDA issued a Cleared decision on March 14, 2014, 176 days after receiving the submission on September 19, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5840.

Submission Details

510(k) Number	K132944 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 19, 2013
Decision Date	March 14, 2014
Days to Decision	176 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF