FDA 510(k) Application Details - K082588

Device Classification Name	Camera, Scintillation (Gamma)   More FDA Info for this Device
510(K) Number	K082588
Device Name	Camera, Scintillation (Gamma)
Applicant	DILON TECHNOLOGIES LLC 12050 JEFFERSON AVE., SUITE 250 NEWPORT NEWS, VA 23606 US Other 510(k) Applications for this Company
Contact	ELAINE DUNCAN Other 510(k) Applications for this Contact
Regulation Number	892.1100   More FDA Info for this Regulation Number
Classification Product Code	IYX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/2008
Decision Date	12/11/2009
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