K-number	K221624
Device name	Avenda Health AI Prostate Cancer Planning Software
Applicant	Avenda Health, Inc.
Product code	POK
Device class	Class II
Decision date	Nov 22, 2022
Decision	Substantially Equivalent
Regulation	892.2060

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Source

View the full FDA submission: accessdata.fda.gov

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Avenda Health AI Prostate Cancer Planning Software

Everything you need for a 510(k) submission. Nothing you don't.