FDA 510(k) Application Details - K181572

Device Classification Name	More FDA Info for this Device
510(K) Number	K181572
Device Name	Workflow Box
Applicant	Mirada Medical Ltd. Oxford Centre for Innovation, New Road Oxford ox1 iby 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	QKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/14/2018
Decision Date	07/10/2018
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	Y
Expedited Review