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/ Artera, Inc.
Artera, Inc.
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K254115
ArteraAI Breast
May 4, 2026
DEN240068
ArteraAI Prostate
July 31, 2025