FDA 510(k)

RadianceTx Radionuclide Brachytherapy Source

Número K: K223465 · 2023-01-11

Data da decisão2023-01-11

Código do produtoKXK

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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