FDA 510(k) Application Details - K211168

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K211168
Device Name	System, X-Ray, Tomography, Computed
Applicant	Philips Healthcare (Suzhou) Co., Ltd. No. 258, ZhongYuan Road, Suzhou Industrial Park Suzhou 215024 CN Other 510(k) Applications for this Company
Contact	Shiguang An Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	JAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2021
Decision Date	11/22/2021
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