Therapixel

FDA Regulatory Profile

Therapixel appears in FDA public data with 0 recalls, 7 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on June 26, 2026.

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K260714MammoScreen® (5)June 26, 2026
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