FDA 510(k) Application Details - K181646

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K181646
Device Name	System, X-Ray, Tomography, Computed
Applicant	Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi 324-8550 JP Other 510(k) Applications for this Company
Contact	Paul Biggins Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	JAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/22/2018
Decision Date	11/16/2018
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	N
Expedited Review