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IXI — Block, Beam-Shaping, Radiation Therapy Class II

FDA Device Classification

Classification Details

Product Code
IXI
Device Class
Class II
Regulation Number
892.5710
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K222639vha deanVHA Radiotherapy BolusNovember 4, 2022
K2140933d systemsVSP BolusMarch 30, 2022
K132236.decimal.DECIMAL PROTON APERTUREOctober 16, 2013
K131150cura medical technologiesCURA COMPENSATORJuly 30, 2013
K123893cura medical technologiesCURA COLLIMATORMarch 4, 2013
K123015.decimal.DECIMAL PHOTON BLOCKNovember 21, 2012
K111676elekta limitedAPEXSeptember 30, 2011
K111759.decimal.DECIMAL ELECTRON APERTURESeptember 9, 2011
K091403oncology techMOD1T COMPENSATORS FOR RADIATION BEAM THERAPYJuly 29, 2009
K091911.decimalBOLUS COMPENSATORJuly 21, 2009
K090417xoftAXXENT FLEXISHIELD MINIJune 23, 2009
K071078.decimal.DECIMAL RANGE COMPENSATORMay 22, 2007
K071077.decimal.DECIMAL APERTUREMay 18, 2007
K062781symtium corporationMOD1 COMPENSATORS FOR RADIATION BEAM THERAPYNovember 21, 2006
K060187topslane internationalTOPSLANE DMLCJuly 27, 2006
K052383innocureINNOCURE IMRT FILTER (COMPENSATORS)March 29, 2006
K040804southeastern radiation products.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATORApril 28, 2004
K040553direx systemsMODIFICATION TO ACCULEAFApril 1, 2004
K032790siemens medical solutions usaMICROMLCOctober 2, 2003
K030609mrc systemsMODULEAFMarch 17, 2003