K-number	DEN240068
Device name	ArteraAI Prostate
Applicant	Artera, Inc.
Product code	SFH
Device class	Class II
Decision date	Jul 31, 2025
Decision	Not Substantially Equivalent
Regulation	864.3755

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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ArteraAI Prostate

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