Advantagesim MD with CT Atlas-Based Contouring and Re-Planning Options

FDA 510(k) K132045 · Ge Hungary Kft

Substantially Equivalent

510(k) numberK132045

Submission

Device name
Advantagesim MD with CT Atlas-Based Contouring and Re-Planning Options
Applicant
Ge Hungary Kft
Waukesha, WI, US
Received
July 2, 2013
Decision date
September 4, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KPQ – System, Simulation, Radiation Therapy
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5840
Specialty
Radiology

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More from Varian Medical Systems, Inc.

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K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationKPQ · Traditional 03/14/2014SE

Questions and answers

When was Advantagesim MD with CT Atlas-Based Contouring and Re-Planning Options cleared by the FDA?

Advantagesim MD with CT Atlas-Based Contouring and Re-Planning Options (K132045) received a 510(k) decision of Substantially Equivalent on September 4, 2013, 64 days after the submission was received.

What is the product code of K132045?

The FDA product code is KPQ – System, Simulation, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5840.