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FDA 510(k)

SIMULIX EVOLUTION

K-Number: K033470 · 2004-02-04

ApplicantNucletron Corporation
Decision Date2004-02-04
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIMULIX EVOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron Corporation. It received FDA 510(k) clearance on 2004-02-04 under 510(k) number K033470. 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 SIMULIX EVOLUTION?

SIMULIX EVOLUTION is a medical device that received FDA 510(k) clearance on 2004-02-04. The listed applicant is Nucletron Corporation. The 510(k) number is K033470.

When did SIMULIX EVOLUTION receive FDA 510(k) clearance?

SIMULIX EVOLUTION received FDA 510(k) clearance on 2004-02-04, under 510(k) number K033470.

Who is the listed applicant for SIMULIX EVOLUTION?

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

What is the FDA product code for SIMULIX EVOLUTION?

The FDA product code for SIMULIX EVOLUTION is KPQ.

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Other records listing Nucletron Corporation as applicant

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.

K103515EQUAL DOSEK090706ONCENTRA SIMULATION 2.3K091154UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330,K082642ONCENTRA RT VIEWER 1.0K080934VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SETK081281OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)

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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.

K132045ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONSGe Hungary KftK101038RAD 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, LLC

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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