FDA 510(k) Application Details - K183013

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K183013
Device Name	System, Image Processing, Radiological
Applicant	Canon Medical Systems Corporation 1385 Shimoishigami Otawara 324-8550 JP Other 510(k) Applications for this Company
Contact	Paul Biggins 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	10/31/2018
Decision Date	11/26/2018
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