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Therapixel

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K243685MammoScreen BDAugust 22, 2025
K243679MammoScreen® (4)July 3, 2025
K241561MammoScreen BDOctober 2, 2024
K240301MammoScreen® (3)August 1, 2024
K211541MammoScreen 2.0November 26, 2021
K192854MammoScreenMarch 25, 2020