FDA 510(k) Application Details - K203784

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K203784
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	Hiroaki Takahashi 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	12/28/2020
Decision Date	02/23/2021
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