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FDA 510(k)

ONCENTRA GYN

K-Number: K080929 · 2008-04-16

ApplicantNucletron Corporation
Decision Date2008-04-16
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ONCENTRA GYN is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron Corporation. It received FDA 510(k) clearance on 2008-04-16 under 510(k) number K080929. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONCENTRA GYN?

ONCENTRA GYN is a medical device that received FDA 510(k) clearance on 2008-04-16. The listed applicant is Nucletron Corporation. The 510(k) number is K080929.

When did ONCENTRA GYN receive FDA 510(k) clearance?

ONCENTRA GYN received FDA 510(k) clearance on 2008-04-16, under 510(k) number K080929.

Who is the listed applicant for ONCENTRA GYN?

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 GYN?

The FDA product code for ONCENTRA GYN is MUJ.

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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: MUJ)

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.

K260750Virtual Cone (1.0)Varian Medical Systems, Inc.K253050RadOncAIInformaiK260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.

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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