FDA 510(k) Application Details - K073456

Device Classification Name	Camera, Scintillation (Gamma)   More FDA Info for this Device
510(K) Number	K073456
Device Name	Camera, Scintillation (Gamma)
Applicant	MEDX, INC. 3456 NORTH RIDGE AVE., #100 ARLINGTON HEIGHTS, IL 60004 US Other 510(k) Applications for this Company
Contact	MICHAEL HANUSHEWSKY 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	12/10/2007
Decision Date	12/20/2007
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	Y
Expedited Review