FDA 510(k) Application Details - K161515

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K161515
Device Name	System, Image Processing, Radiological
Applicant	Client Outlook Inc. 103 Bauer Place, Suite #3 Waterloo N2L6B5 CA Other 510(k) Applications for this Company
Contact	Christie Eby 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	06/02/2016
Decision Date	11/15/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review