FDA 510(k) Application Details - K101391

Device Classification Name	Camera, Scintillation (Gamma)   More FDA Info for this Device
510(K) Number	K101391
Device Name	Camera, Scintillation (Gamma)
Applicant	SCANDIA CORPORATION 10200 DENNIS DRIVE SUITE 5 URBANDALE, IA 50322 US Other 510(k) Applications for this Company
Contact	DAVID ASKEW 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	05/18/2010
Decision Date	08/04/2010
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