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FDA 510(k)

ONCENTRA SIMULATION 2.3

K-Number: K090706 · 2009-06-15

ApplicantNucletron Corporation
Decision Date2009-06-15
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ONCENTRA SIMULATION 2.3 is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron Corporation. It received FDA 510(k) clearance on 2009-06-15 under 510(k) number K090706. 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 ONCENTRA SIMULATION 2.3?

ONCENTRA SIMULATION 2.3 is a medical device that received FDA 510(k) clearance on 2009-06-15. The listed applicant is Nucletron Corporation. The 510(k) number is K090706.

When did ONCENTRA SIMULATION 2.3 receive FDA 510(k) clearance?

ONCENTRA SIMULATION 2.3 received FDA 510(k) clearance on 2009-06-15, under 510(k) number K090706.

Who is the listed applicant for ONCENTRA SIMULATION 2.3?

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 ONCENTRA SIMULATION 2.3?

The FDA product code for ONCENTRA SIMULATION 2.3 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 DOSEK091154UTRECHT 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)K080871TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS

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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, LLCK083591IKOENGELO, 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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