ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION

System, Simulation, Radiation Therapy

GE HUNGARY KFT

The following data is part of a premarket notification filed by Ge Hungary Kft with the FDA for Advantagesim Md Mr Pelvic Organ At Risk Segmentation.

Pre-market Notification Details

• Device ID: K132944
• 510k Number: K132944
• Device Name: ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION
• Classification: System, Simulation, Radiation Therapy
• Applicant: GE HUNGARY KFT DBA GE HEALTHCARE 3000 N GRANDVIEW Waukesha, WI 53188
• Contact: Stephen Slavens
• Correspondent: Stephen Slavens; GE HUNGARY KFT DBA GE HEALTHCARE 3000 N GRANDVIEW Waukesha, WI 53188
• Product Code: KPQ
• CFR Regulation Number: 892.5840 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-09-19
• Decision Date: 2014-03-14
• Summary: summary