FDA 510(k) Application Details - K140445

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K140445
Device Name	System, Image Processing, Radiological
Applicant	IMAGING SCIENCES INTERNATIONAL, LLC 1910 NORTH PENN RD. HATFIELD, PA 19440 US Other 510(k) Applications for this Company
Contact	SANJAY AHUJA 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	02/21/2014
Decision Date	04/23/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review