FDA 510(k) Application Details - K133719

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K133719
Device Name	System, X-Ray, Angiographic
Applicant	HAMAMATSU PHOTONICS, K.K. 700 13TH STREET, NW SUITE 1200 WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	JEFFREY K SHAPIRO 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	12/05/2013
Decision Date	03/27/2014
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