FDA 510(k) Application Details - K092018

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K092018
Device Name	Accelerator, Linear, Medical
Applicant	IBA DOSIMETRY GMBH 3150 STAGE POST DR SUITE 110 BARTLETT, TN 38133 US Other 510(k) Applications for this Company
Contact	CHUCK LINDLEY Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	IYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2009
Decision Date	09/18/2009
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	N
Expedited Review