FDA 510(k) Application Details - K221564

Device Classification Name	More FDA Info for this Device
510(K) Number	K221564
Device Name	Brainomix 360 e-ASPECTS
Applicant	Brainomix Limited Suite 11-14, Suffolk House, 263 Banbury Road Oxford OX2 7HN GB Other 510(k) Applications for this Company
Contact	Gwilym Owen 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	05/31/2022
Decision Date	02/23/2023
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