FDA 510(k) Application Details - K103554

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K103554
Device Name	System, Image Processing, Radiological
Applicant	EPONATECH LLC 1485 TREAT BOULEVARD SUITE 200 WALNUT CREEK, CA 94597 US Other 510(k) Applications for this Company
Contact	K. BRIAN MATLOCK 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	12/03/2010
Decision Date	12/20/2011
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