FDA 510(k) Application Details - K121657

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K121657
Device Name	Accelerator, Linear, Medical
Applicant	PROTON SYSTEMS 611 WEST 5TH STREET THIRD FLOOR AUSTIN, TX 78701 US Other 510(k) Applications for this Company
Contact	MIKE BEGALA 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	06/05/2012
Decision Date	10/23/2012
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