FDA 510(k) Application Details - K211780

Device Classification Name	More FDA Info for this Device
510(K) Number	K211780
Device Name	ZEN-2090 Turbo
Applicant	Genoray Co., Ltd. 512, 560, Dunchon-daero, Jungwon-gu Seongnam-si 13230 KR Other 510(k) Applications for this Company
Contact	Sookyung Choi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/09/2021
Decision Date	03/09/2022
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