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FDA 510(k)

APPLICATORS FOR AFTERLOADING BRACHYTHERAPY

K-Number: K082530 · 2008-10-30

ApplicantIsodose Control B.V.
Decision Date2008-10-30
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

APPLICATORS FOR AFTERLOADING BRACHYTHERAPY is the device name listed in this FDA 510(k) record. The listed applicant is Isodose Control B.V.. It received FDA 510(k) clearance on 2008-10-30 under 510(k) number K082530. 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 APPLICATORS FOR AFTERLOADING BRACHYTHERAPY?

APPLICATORS FOR AFTERLOADING BRACHYTHERAPY is a medical device that received FDA 510(k) clearance on 2008-10-30. The listed applicant is Isodose Control B.V.. The 510(k) number is K082530.

When did APPLICATORS FOR AFTERLOADING BRACHYTHERAPY receive FDA 510(k) clearance?

APPLICATORS FOR AFTERLOADING BRACHYTHERAPY received FDA 510(k) clearance on 2008-10-30, under 510(k) number K082530.

Who is the listed applicant for APPLICATORS FOR AFTERLOADING BRACHYTHERAPY?

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

What is the FDA product code for APPLICATORS FOR AFTERLOADING BRACHYTHERAPY?

The FDA product code for APPLICATORS FOR AFTERLOADING BRACHYTHERAPY is JAQ.

Related Clinical Trials

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Other records listing Isodose Control B.V. 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.

K091145FLEXIPLAN 3D AND 3D+K081112FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEMK070574FLEXITRON

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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