ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION— 510(k) K132944

Name: FDA 510(k) clearance K132944
Creator: U.S. Food and Drug Administration
Published: 2014-03-14

Substantially Equivalent

Ge Hungary Kft

FDA 510(k) clearance K132944 for ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION, Substantially Equivalent on 2014-03-14. Applicant: Ge Hungary Kft. Device class: 2.

Clearance details

Applicant: Ge Hungary Kft
Product code: Code KPQ
Device class: Class 2
Regulation: 21 CFR 892.5840
Advisory panel: Radiology
Date received: 2013-09-19
Decision date: 2014-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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