FDA 510(k) Application Details - K152813

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K152813
Device Name	System, X-Ray, Stationary
Applicant	ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD. NO. 16 CUIMING ROAD YAT-SEN SCIENTIFIC INDUSTRIAL PARK TIANJIN ECONOMIC TECHNOLOGICAL DEVELOPME 301726 CN Other 510(k) Applications for this Company
Contact	JU PENG 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	09/28/2015
Decision Date	12/02/2016
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