FDA 510(k) Application Details - K231837

Device Classification Name	More FDA Info for this Device
510(K) Number	K231837
Device Name	Brainomix 360 Triage LVO
Applicant	Brainomix Limited First Floor, Seacourt Tower West Way Oxford OX2 0JJ GB Other 510(k) Applications for this Company
Contact	Thais Sala Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/22/2023
Decision Date	09/28/2023
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