FDA 510(k) Application Details - K220910

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K220910
Device Name	System, X-Ray, Tomography, Computed
Applicant	Hangzhou Deepwise & league of PHD Technology Co.,Ltd. Room 705, Building 8, 1818-2 Wenyi West Road, Yuhang District Hangzhou 311121 CN Other 510(k) Applications for this Company
Contact	Hailong Xu 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	03/29/2022
Decision Date	08/11/2022
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