FDA 510(k) Application Details - K201725

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K201725
Device Name	System, X-Ray, Stationary
Applicant	Philips Healthcare (Suzhou) Co., Lit. No. 258, ZhongYuan Road Suzhou Industrial Park Suzhou 215024 CN Other 510(k) Applications for this Company
Contact	Claire Zhang Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	KPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/2020
Decision Date	07/10/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review