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Brainomix Limited

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251983Brainomix 360 Triage StrokeAugust 26, 2025
K242411Brainomix 360 e-LungFebruary 19, 2025
K243294Brainomix 360 e-ASPECTSFebruary 14, 2025
K242123Brainomix 360 e-CTAJanuary 6, 2025
K233875Brainomix 360 e-LungMay 13, 2024
K232496Brainomix 360 Triage StrokeNovember 21, 2023
K231837Brainomix 360 Triage LVOSeptember 28, 2023
K231656Brainomix 360 e-MRIAugust 30, 2023
K231195Brainomix 360 Triage ICHJuly 27, 2023
K223555Brainomix 360 e-CTPJune 1, 2023
K221564Brainomix 360 e-ASPECTSFebruary 23, 2023
K192692Brainomix 360 e-CTAMay 28, 2020