FDA 510(k) Application Details - K181983

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K181983
Device Name	X-Ray, Tomography, Computed, Dental
Applicant	PreXion Corporation 1-14-1 Kandasuda-cho Chiyoda-ku 101-0041 JP Other 510(k) Applications for this Company
Contact	Katsumi Hayashi Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	OAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2018
Decision Date	08/17/2018
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