Class Class II

ArteraAI Prostate (DEN240068)

DEN240068 2025-07-31 Direct
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Description

ArteraAI Prostate by Artera, Inc. — FDA 510(k) cleared pathology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberDEN240068
Clearance Date2025-07-31
Clearance TypeDirect
Product CodeSFH
Regulation Number864.3755

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