FDA 510(k) Application Details - K063391

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K063391
Device Name	System, Image Processing, Radiological
Applicant	SAPHENEIA COMMERCIAL PRODUCTS AB 932 NORTH STATE STREET JACKSON, MS 39202-2613 US Other 510(k) Applications for this Company
Contact	RICK MANCILLA 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	11/09/2006
Decision Date	04/26/2007
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