Cleared Traditional

ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS

K132045 · Ge Hungary Kft · Radiology

Sep 2013

Decision

64d

Days

Class 2

Risk

About This 510(k) Submission

K132045 is an FDA 510(k) clearance for the ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS, 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 September 4, 2013, 64 days after receiving the submission on July 2, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5840.

Submission Details

510(k) Number	K132045 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 02, 2013
Decision Date	September 04, 2013
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF