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FDA 510(k)

VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET

K-Number: K080934 · 2008-05-28

ApplicantNucletron Corporation
Decision Date2008-05-28
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron Corporation. It received FDA 510(k) clearance on 2008-05-28 under 510(k) number K080934. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET?

VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET is a medical device that received FDA 510(k) clearance on 2008-05-28. The listed applicant is Nucletron Corporation. The 510(k) number is K080934.

When did VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET receive FDA 510(k) clearance?

VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET received FDA 510(k) clearance on 2008-05-28, under 510(k) number K080934.

Who is the listed applicant for VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET?

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 VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET?

The FDA product code for VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET is JAQ.

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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 1.0K081281OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)K080871TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS

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Related Devices (Code: JAQ)

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.

K262383LumenCare AzureNucletron B.V.K252717MAASTRO Rectal Applicator SetVarian Medical SystemsK251037Rectal ApplicatorNucletron B.V.K252884Guided Aarhus Applicator SetVarian Medical SystemsK250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc.K250289Intracavitary/Interstitial SystemVarian Medical Systems

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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