FDA 510(k) Application Details - K131348

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K131348
Device Name	System, Image Processing, Radiological
Applicant	INFOMED SERVICIOS INFORMATICOS S.L. VIA AUGUSTA 158, 4TH FLOOR BARCELONA 08006 ES Other 510(k) Applications for this Company
Contact	SANTIAGO SOLA 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	05/10/2013
Decision Date	08/05/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review