FDA 510(k) Application Details - K131428

Device Classification Name	System,Planning,Radiation Therapy Treatment   More FDA Info for this Device
510(K) Number	K131428
Device Name	System,Planning,Radiation Therapy Treatment
Applicant	ACOUSTIC MEDSYSTEMS, INC. 208 BURWASH AVE. SAVOY, IL 61874 US Other 510(k) Applications for this Company
Contact	JENNIFER WILLIAMS Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	MUJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/17/2013
Decision Date	07/16/2013
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