FDA 510(k) Application Details - K223261

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K223261
Device Name	System, X-Ray, Tomography, Computed
Applicant	Canon Medical Informatics, Inc. 5850 Opus Parkway, Suite 300 Minnetonka, MN 55343 US Other 510(k) Applications for this Company
Contact	Vincent Swenson 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	10/24/2022
Decision Date	07/13/2023
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