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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 the device name listed in this FDA 510(k) record. The listed applicant is Radiance Therapeutics, Inc.. It received FDA 510(k) clearance on 2023-01-11 under 510(k) 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. The listed applicant is Radiance Therapeutics, Inc.. The 510(k) number is K223465.

When did RadianceTx Radionuclide Brachytherapy Source receive FDA 510(k) clearance?

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

Who is the listed applicant for RadianceTx Radionuclide Brachytherapy Source?

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

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

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

Related Devices (Code: KXK)

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.

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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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