FDA 510(k) Application Details - K190320

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K190320
Device Name	X-Ray, Tomography, Computed, Dental
Applicant	PreXion Corporation 1-14-1, Kanda Suda-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	02/13/2019
Decision Date	04/15/2019
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