FDA 510(k) Application Details - K200469

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K200469
Device Name	X-Ray, Tomography, Computed, Dental
Applicant	Genoray Co.,Ltd # 512, 560, Dunchon-daero, Jungwon-gu, Seongnam-si 13230 KR Other 510(k) Applications for this Company
Contact	Hyunju Hwang 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	02/26/2020
Decision Date	09/16/2020
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