FDA 510(k) Application Details - K151780

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K151780
Device Name	System, X-Ray, Angiographic
Applicant	PIE MEDICAL IMAGING B.V. PHILIPSWEG 1 MAASTRICHT 6227 AJ NL Other 510(k) Applications for this Company
Contact	FLORIE DANIELS Other 510(k) Applications for this Contact
Regulation Number	892.1600   More FDA Info for this Regulation Number
Classification Product Code	IZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2015
Decision Date	03/11/2016
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