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FDA 510(k)

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

K-Number: K132045 · 2013-09-04

ApplicantGe Hungary Kft
Decision Date2013-09-04
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS is the device name listed in this FDA 510(k) record. The listed applicant is Ge Hungary Kft. It received FDA 510(k) clearance on 2013-09-04 under 510(k) number K132045. The device is classified under product code KPQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS?

ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS is a medical device that received FDA 510(k) clearance on 2013-09-04. The listed applicant is Ge Hungary Kft. The 510(k) number is K132045.

When did ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS receive FDA 510(k) clearance?

ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS received FDA 510(k) clearance on 2013-09-04, under 510(k) number K132045.

Who is the listed applicant for ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS?

The FDA 510(k) record lists Ge Hungary Kft as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS?

The FDA product code for ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS is KPQ.

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Related Devices (Code: KPQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K101038RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGERAcceletronics Digital Imaging, LLCK090706ONCENTRA SIMULATION 2.3Nucletron CorporationK083591IKOENGELO, VERSION 2Ikoetech, LLCK072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALNucletron Corp.K061006IKOENGELOIkoetech, LLCK052361SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAMNucletron Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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