FDA 510(k) Application Details - K101042

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K101042
Device Name	System, X-Ray, Stationary
Applicant	ACCOGENT LLC 644 NORTH LAKE WAY PALM BEACH, FL 33480 US Other 510(k) Applications for this Company
Contact	TRISTAN TICE Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	KPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2010
Decision Date	10/29/2010
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