Koios Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0820-2020Class IIKoios DS Breast <series 1.0>. The device is a software application which assists skilled physicians December 31, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K242130Koios DSNovember 15, 2024
K212616Koios DSDecember 16, 2021
K190442Koios DS for BreastJuly 3, 2019