FDA 510(k) Application Details - K190856

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K190856
Device Name	X-Ray, Tomography, Computed, Dental
Applicant	Epica International Inc. 2753 Camino Capistrano. Suite A-101 San Clemente, CA 92672 US Other 510(k) Applications for this Company
Contact	Daniel Naimey 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	04/02/2019
Decision Date	09/20/2019
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