FDA 510(k) Application Details - K113708

Device Classification Name	More FDA Info for this Device
510(K) Number	K113708
Device Name	ORTHOSCAN MOBILE DI MINI C-ARM
Applicant	ORTHOSCAN, INC. 8212 E. EVANS ROAD SCOTTSDALE, AZ 85260 US Other 510(k) Applications for this Company
Contact	CHRIS EAVES Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2011
Decision Date	01/05/2012
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