FDA 510(k) Application Details - K230140

Device Classification Name	Cabinet,X-Ray System   More FDA Info for this Device
510(K) Number	K230140
Device Name	Cabinet,X-Ray System
Applicant	CompAI Healthcare (Suzhou) Co.,ltd Room 3A05, Building 2, No.8 Changting Road, High-tech Zone Suzhou 215151 CN Other 510(k) Applications for this Company
Contact	Xueqiao Wang Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	MWP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/18/2023
Decision Date	04/24/2023
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