FDA 510(k) Application Details - K143156

Device Classification Name	Camera, Scintillation (Gamma)   More FDA Info for this Device
510(K) Number	K143156
Device Name	Camera, Scintillation (Gamma)
Applicant	GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION- EDUARDO PEIMO YUFERA 3 VALENCIA 46012 ES Other 510(k) Applications for this Company
Contact	Jose Montes 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	11/03/2014
Decision Date	11/18/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review