FDA 510(k) Application Details - K210900

Device Classification Name	More FDA Info for this Device
510(K) Number	K210900
Device Name	Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
Applicant	Canon Medical Systems Corporation 1385 Shimoshigami Otawara-shi 324-8550 JP Other 510(k) Applications for this Company
Contact	Paul Biggins 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	03/26/2021
Decision Date	04/12/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review