FDA 510(k) Application Details - K171194

Device Classification Name	More FDA Info for this Device
510(K) Number	K171194
Device Name	AS-10, CXDI-401RF
Applicant	Canon, Inc. 9-1, Imaikami-Cho,Nakahara-Ku Kawasaki 211-8501 JP Other 510(k) Applications for this Company
Contact	Shinji Mori Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/2017
Decision Date	05/24/2017
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