FDA 510(k) Application Details - K092328

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K092328
Device Name	System, Image Processing, Radiological
Applicant	BARTRON MEDICAL IMAGING, INC. 990 WASHINGTON STREET DEDHAM, MA 02026 US Other 510(k) Applications for this Company
Contact	ZVI LADIN Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2009
Decision Date	07/26/2010
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	N
Expedited Review