FDA 510(k) Application Details - K220700

Device Classification Name	System, X-Ray, Mobile   More FDA Info for this Device
510(K) Number	K220700
Device Name	System, X-Ray, Mobile
Applicant	Yian Medical Technology (Haining) Co., Ltd 1st Floor Area 1, 2nd Floor Area 1, Building A, No. 2 Caohejing Road, Haining Economic Development Zone Jiaxing CN Other 510(k) Applications for this Company
Contact	Zhiqin Yu Other 510(k) Applications for this Contact
Regulation Number	892.1720   More FDA Info for this Regulation Number
Classification Product Code	IZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/10/2022
Decision Date	05/04/2022
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