FDA 510(k) Application Details - K112981

Device Classification Name	System, Radiation Therapy, Charged-Particle, Medical   More FDA Info for this Device
510(K) Number	K112981
Device Name	System, Radiation Therapy, Charged-Particle, Medical
Applicant	SUN NUCLEAR CORP. 425 PINEDA COURT MELBOURNE, FL 32940 US Other 510(k) Applications for this Company
Contact	NOEL DOWNEY Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	LHN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/06/2011
Decision Date	01/25/2012
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