ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS— 510(k) K132045

Name: FDA 510(k) clearance K132045
Creator: U.S. Food and Drug Administration
Published: 2013-09-04

Substantially Equivalent

Ge Hungary Kft

FDA 510(k) clearance K132045 for ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS, Substantially Equivalent on 2013-09-04. 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: 2013-07-02
Decision date: 2013-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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