FDA 510(k) Application Details - K212279

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K212279
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	iRay Technology Taicang Ltd. No. 33 Xinggang Rd. Taicang Port Economic & Technological Development Zone Taicang 215434 CN Other 510(k) Applications for this Company
Contact	Guo Wu 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	07/20/2021
Decision Date	10/07/2021
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