FDA 510(k) Application Details - K050996

Device Classification Name	More FDA Info for this Device
510(K) Number	K050996
Device Name	O-ARM IMAGING SYSTEM
Applicant	BREAKAWAY IMAGING, LLC 300 FOSTER STREET LITTLETON, MA 01460 US Other 510(k) Applications for this Company
Contact	WOLFGANG KRULL 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	04/20/2005
Decision Date	05/05/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	Y
Expedited Review