FDA 510(k) Applications for Medical Device Product Code: IXI (Block, Beam-Shaping, Radiation Therapy)

FDA 510(k) Applications for Medical Device Product Code "IXI"
(Block, Beam-Shaping, Radiation Therapy)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K071077	.DECIMAL, INC.	.DECIMAL APERTURE	05/18/2007
K111759	.DECIMAL, INC.	.DECIMAL ELECTRON APERTURE	09/09/2011
K123015	.DECIMAL, INC.	.DECIMAL PHOTON BLOCK	11/21/2012
K132236	.DECIMAL, INC.	.DECIMAL PROTON APERTURE	10/16/2013
K071078	.DECIMAL, INC.	.DECIMAL RANGE COMPENSATOR	05/22/2007
K091911	.DECIMAL, INC.	BOLUS COMPENSATOR	07/21/2009
K001163	3D LINE USA, INC.	DMLC IV-ERGO	10/23/2000
K214093	3D Systems	VSP Bolus	03/30/2022
K973953	AKTINA MEDICAL PHYSICS CORP.	AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM	01/14/1998
K974239	AKTINA MEDICAL PHYSICS CORP.	AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM	02/10/1998
K010172	ARPLAY MEDICAL S.A.	LEAD BLOCKS	04/18/2001
K972016	C.L. MCINTOSH & ASSOC., INC.	AUTIMO 2.5-D AND AUTIMO 3-D	12/04/1997
K000137	COMPUTERIZED MEDICAL SYSTEMS, INC.	ENHANCED COMPENSATING FILTER	04/17/2000
K123893	CURA MEDICAL TECHNOLOGIES, LLC	CURA COLLIMATOR	03/04/2013
K131150	CURA MEDICAL TECHNOLOGIES, LLC	CURA COMPENSATOR	07/30/2013
K040553	DIREX SYSTEMS CORP.	MODIFICATION TO ACCULEAF	04/01/2004
K111676	Elekta Limited	APEX	09/30/2011
K970303	GENERAL ELECTRIC CO.	SATURNE MULTILEAF COLLIMATOR	04/25/1997
K052383	INNOCURE, LLC	INNOCURE IMRT FILTER (COMPENSATORS)	03/29/2006
K981992	MED-TEC,INC.	ELECTRON WEDGE MODEL MT-EW-1000	12/15/1998
K013875	MED-TEC,INC.	MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE	09/27/2002
K971001	MEDIZINTECHNIK, GMBH	AUTIMO	06/13/1997
K011816	MRC SYSTEMS GMBH	MINI MULTILEAF COLLIMATOR, MODEL KMI	09/07/2001
K030609	MRC SYSTEMS GMBH	MODULEAF	03/17/2003
K091403	ONCOLOGY TECH, LLC	MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY	07/29/2009
K021987	S&S PAR SCIENTIFIC	PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY	12/27/2002
K990491	SIEMENS MEDICAL SOLUTIONS USA, INC.	ANGIO-CT MIYABI	04/05/1999
K032790	SIEMENS MEDICAL SOLUTIONS USA, INC.	MICROMLC	10/02/2003
K961902	SIEMENS MEDICAL SOLUTIONS USA, INC.	SIEMENS BEAM SHAPER	08/08/1996
K954248	SIEMENS MEDICAL SOLUTIONS USA, INC.	SIEMENS VIRTURAL WEDGE	01/05/1996
K040804	SOUTHEASTERN RADIATION PRODUCTS, INC.	.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR	04/28/2004
K000349	STRYKER LEIBINGER	MOTORIZED MICRO MULTILEAF COLLIMATOR	05/03/2000
K062781	SYMTIUM CORPORATION	MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY	11/21/2006
K060187	TOPSLANE INTERNATIONAL, LLC	TOPSLANE DMLC	07/27/2006
K222639	VHA DEAN	VHA Radiotherapy Bolus	11/04/2022
K090417	XOFT, INC.	AXXENT FLEXISHIELD MINI	06/23/2009

FDA 510(k) Applications for Medical Device Product Code "IXI" (Block, Beam-Shaping, Radiation Therapy)

FDA 510(k) Applications for Medical Device Product Code "IXI"
(Block, Beam-Shaping, Radiation Therapy)