FDA 510(k) Application Details - K113076

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K113076
Device Name	System, Image Processing, Radiological
Applicant	PIE MEDICAL IMAGING B.V. BECANUSSTRAAT 13 D MAASTRICHT 6216 BX NL Other 510(k) Applications for this Company
Contact	Florie Daniels 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	10/17/2011
Decision Date	01/30/2012
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