FDA 510(k) Application Details - K120344

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K120344
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	RADIADYNE, LLC (SPECIFICATION DEVELOPER) 11931 WICKCHESTER LANE HOUSTON, TX 77043 US Other 510(k) Applications for this Company
Contact	STUART R GOLDMAN Other 510(k) Applications for this Contact
Regulation Number	892.5700   More FDA Info for this Regulation Number
Classification Product Code	JAQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/03/2012
Decision Date	05/03/2012
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