FDA 510(k) Application Details - K202664

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K202664
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	Sota Precision Optics, Inc. dba SOTA Imaging 1073 North Batavia Street, Suite B Orange, CA 92867 US Other 510(k) Applications for this Company
Contact	Bumsuk Kim Other 510(k) Applications for this Contact
Regulation Number	872.1800   More FDA Info for this Regulation Number
Classification Product Code	MUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/14/2020
Decision Date	11/06/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review