FDA 510(k) Application Details - K092134

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K092134
Device Name	System, Image Processing, Radiological
Applicant	STATRAD, LLC 4747 VIEWRIDGE AVE. SUITE 107 SAN DIEGO, CA 92123 US Other 510(k) Applications for this Company
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	07/15/2009
Decision Date	09/15/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review