K-number	K223465
Device name	RadianceTx Radionuclide Brachytherapy Source
Applicant	Radiance Therapeutics, Inc.
Product code	KXK
Device class	Class II
Decision date	Jan 11, 2023
Decision	Substantially Equivalent
Regulation	892.5730

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Source

View the full FDA submission: accessdata.fda.gov

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RadianceTx Radionuclide Brachytherapy Source

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