FDA 510(k) Application Details - K161341

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K161341
Device Name	System, Image Processing, Radiological
Applicant	LIFETRACK MEDICAL SYSTEMS, INC. 1007 ONE WORLD PLACE, 32ND STREET, BGC TAGUIG CITY 1634 PH Other 510(k) Applications for this Company
Contact	ERIC SCHULZE Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2016
Decision Date	04/05/2017
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