FDA 510(k) Application Details - K243294

Device Classification Name	More FDA Info for this Device
510(K) Number	K243294
Device Name	Brainomix 360 e-ASPECTS
Applicant	Brainomix Limited First Floor, Seacourt Tower West Way Oxford OX2 0JJ GB Other 510(k) Applications for this Company
Contact	Delanyo Mensah Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/2024
Decision Date	02/14/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review