FDA 510(k) Application Details - K071195

Device Classification Name	Camera, Scintillation (Gamma)   More FDA Info for this Device
510(K) Number	K071195
Device Name	Camera, Scintillation (Gamma)
Applicant	ANI-KAL II, LLC 7570 SW WEST GATE WAY PORTLAND, OR 97225 US Other 510(k) Applications for this Company
Contact	GERBAIL T KRISHNAMURTHY, MD 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	04/30/2007
Decision Date	06/20/2007
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	N
Expedited Review