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FDA 510(k)

RadianceTx Radionuclide Brachytherapy Source

K-Number: K223465 · 2023-01-11

ApplicantRadiance Therapeutics, Inc.
Decision Date2023-01-11
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RadianceTx Radionuclide Brachytherapy Source is a medical device manufactured by Radiance Therapeutics, Inc.. It received FDA 510(k) clearance on 2023-01-11 under approval number K223465. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RadianceTx Radionuclide Brachytherapy Source?

RadianceTx Radionuclide Brachytherapy Source is a medical device that received FDA 510(k) clearance on 2023-01-11. It is manufactured by Radiance Therapeutics, Inc.. The 510(k) number is K223465.

When was RadianceTx Radionuclide Brachytherapy Source approved by the FDA?

RadianceTx Radionuclide Brachytherapy Source received FDA 510(k) clearance on 2023-01-11, under approval number K223465.

What company makes RadianceTx Radionuclide Brachytherapy Source?

RadianceTx Radionuclide Brachytherapy Source is manufactured by Radiance Therapeutics, Inc..

What is the FDA product code for RadianceTx Radionuclide Brachytherapy Source?

The FDA product code for RadianceTx Radionuclide Brachytherapy Source is KXK.

Related Clinical Trials

NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING

Related Devices (Code: KXK)

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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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