FDA 510(k) Application Details - K123015

Device Classification Name	Block, Beam-Shaping, Radiation Therapy   More FDA Info for this Device
510(K) Number	K123015
Device Name	Block, Beam-Shaping, Radiation Therapy
Applicant	.DECIMAL, INC. 121 CENTRAL PARK PLACE SANFORD, FL 32771 US Other 510(k) Applications for this Company
Contact	KYM RUPP Other 510(k) Applications for this Contact
Regulation Number	892.5710   More FDA Info for this Regulation Number
Classification Product Code	IXI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2012
Decision Date	11/21/2012
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