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FDA 510(k)

ONCENTRA PROSTATE 4.0

K-Number: K112420 · 2011-11-18

ApplicantNucletron
Decision Date2011-11-18
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ONCENTRA PROSTATE 4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron. It received FDA 510(k) clearance on 2011-11-18 under 510(k) number K112420. 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 ONCENTRA PROSTATE 4.0?

ONCENTRA PROSTATE 4.0 is a medical device that received FDA 510(k) clearance on 2011-11-18. The listed applicant is Nucletron. The 510(k) number is K112420.

When did ONCENTRA PROSTATE 4.0 receive FDA 510(k) clearance?

ONCENTRA PROSTATE 4.0 received FDA 510(k) clearance on 2011-11-18, under 510(k) number K112420.

Who is the listed applicant for ONCENTRA PROSTATE 4.0?

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

What is the FDA product code for ONCENTRA PROSTATE 4.0?

The FDA product code for ONCENTRA PROSTATE 4.0 is JAQ.

Related Clinical Trials

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Other records listing Nucletron 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.

K113102ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNINGK111973VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET

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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