FDA 510(k) Application Details - K192692

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K192692
Device Name	System, Image Processing, Radiological
Applicant	Brainomix Limited Suites 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	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2019
Decision Date	05/28/2020
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