FDA 510(k) Application Details - K203314

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K203314
Device Name	System, Tomography, Computed, Emission
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	892.1200   More FDA Info for this Regulation Number
Classification Product Code	KPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/10/2020
Decision Date	04/23/2021
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