Product Code: IXI FDA class 2 21 CFR 892.5710

Block, Beam-Shaping, Radiation Therapy

Radiology

A radiation therapy beam-shaping block is a custom or modular attenuating block, typically made of high-density metal alloy, placed in the path of a therapeutic radiation beam to shape the treatment field and protect surrounding healthy tissue from unnecessary irradiation. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IXI, regulated under 21 CFR 892.5710, within the Radiology medical specialty. This device is eligible for third party 510(k) review.

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FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: IXI
Device Class: FDA class 2
Regulation Number: 892.5710
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 51 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253025	Ricoh 3D for Healthcare Bolus	Apr 06, 2026	Substantially Equivalent	Ricoh 3D For Healthcare, LLC
K222639	VHA Radiotherapy Bolus	Nov 04, 2022	Substantially Equivalent	Vha Dean
K214093	VSP Bolus	Mar 30, 2022	Substantially Equivalent	3D Systems
K132236	.DECIMAL PROTON APERTURE	Oct 16, 2013	Substantially Equivalent	.Decimal, Inc.
K131150	CURA COMPENSATOR	Jul 30, 2013	Substantially Equivalent	Cura Medical Technologies, LLC
K123893	CURA COLLIMATOR	Mar 04, 2013	Substantially Equivalent	Cura Medical Technologies, LLC
K123015	.DECIMAL PHOTON BLOCK	Nov 21, 2012	Substantially Equivalent	.Decimal, Inc.
K111676	APEX	Sep 30, 2011	Substantially Equivalent	Elekta Limited
K111759	.DECIMAL ELECTRON APERTURE	Sep 09, 2011	Substantially Equivalent	.Decimal, Inc.
K091403	MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY	Jul 29, 2009	Substantially Equivalent	Oncology Tech, LLC
K091911	BOLUS COMPENSATOR	Jul 21, 2009	Substantially Equivalent	.Decimal, Inc.
K090417	AXXENT FLEXISHIELD MINI	Jun 23, 2009	Substantially Equivalent	Xoft, Inc.
K071078	.DECIMAL RANGE COMPENSATOR	May 22, 2007	Substantially Equivalent	.Decimal, Inc.
K071077	.DECIMAL APERTURE	May 18, 2007	Substantially Equivalent	.Decimal, Inc.
K062781	MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY	Nov 21, 2006	Substantially Equivalent	Symtium Corporation
K060187	TOPSLANE DMLC	Jul 27, 2006	Substantially Equivalent	Topslane International, LLC
K052383	INNOCURE IMRT FILTER (COMPENSATORS)	Mar 29, 2006	Substantially Equivalent	Innocure, LLC
K040804	.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR	Apr 28, 2004	Substantially Equivalent	Southeastern Radiation Products, Inc.
K040553	MODIFICATION TO ACCULEAF	Apr 01, 2004	Substantially Equivalent	Direx Systems Corp.
K032790	MICROMLC	Oct 02, 2003	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K030609	MODULEAF	Mar 17, 2003	Substantially Equivalent	Mrc Systems GmbH
K021987	PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY	Dec 27, 2002	Substantially Equivalent	S&S Par Scientific
K013875	MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE	Sep 27, 2002	Substantially Equivalent	Med-Tec,Inc.
K011816	MINI MULTILEAF COLLIMATOR, MODEL KMI	Sep 07, 2001	Substantially Equivalent	Mrc Systems GmbH
K010172	LEAD BLOCKS	Apr 18, 2001	Substantially Equivalent	Arplay Medical S.A.
K001163	DMLC IV-ERGO	Oct 23, 2000	Substantially Equivalent	3D Line USA, Inc.
K000349	MOTORIZED MICRO MULTILEAF COLLIMATOR	May 03, 2000	Substantially Equivalent	Stryker Leibinger
K000137	ENHANCED COMPENSATING FILTER	Apr 17, 2000	Substantially Equivalent	Computerized Medical Systems, Inc.
K990491	ANGIO-CT MIYABI	Apr 05, 1999	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K981992	ELECTRON WEDGE MODEL MT-EW-1000	Dec 15, 1998	Substantially Equivalent	Med-Tec,Inc.
K974239	AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM	Feb 10, 1998	Substantially Equivalent	Aktina Medical Physics Corp.
K973953	AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM	Jan 14, 1998	Substantially Equivalent	Aktina Medical Physics Corp.
K972016	AUTIMO 2.5-D AND AUTIMO 3-D	Dec 04, 1997	Substantially Equivalent	C.L. Mcintosh & Assoc., Inc.
K971001	AUTIMO	Jun 13, 1997	Substantially Equivalent	Medizintechnik, GmbH
K970303	SATURNE MULTILEAF COLLIMATOR	Apr 25, 1997	Substantially Equivalent	General Electric Co.
K961902	SIEMENS BEAM SHAPER	Aug 08, 1996	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K954248	SIEMENS VIRTURAL WEDGE	Jan 05, 1996	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K953227	CASPER	Nov 22, 1995	Substantially Equivalent	Northwest Medical Physics Center
K953894	SIEMENS MULTILEAF COLLIMATOR	Nov 13, 1995	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K940412	MULTILEAF INTENSITY MODULATING COLLIMATOR	Feb 15, 1995	Substantially Equivalent	Nomos Corp.
K943343	FIELD ABUTMENT WEDGE	Dec 23, 1994	Substantially Equivalent	Medtec, Inc.
K941719	360 DEG. ROTATING 1/2 BEAM BLOCK	Jul 18, 1994	Substantially Equivalent	Medtec, Inc.
K904124	PHILIPS MULTILEAF COLLIMATOR (MLC)	Jan 30, 1991	Substantially Equivalent	Philips Medical Systems, Inc.
K901567	THE HUESTIS COMPU-PLOTTER	May 31, 1990	Substantially Equivalent	Huestis Machine Corp.
K893464	VARIAN MULTILEAF COLLIMATOR	Aug 10, 1989	Substantially Equivalent	Varian Assoc., Inc.
K883317	DCD-1 (DIGITAL CONTOUR DETECT-RADIAT THERAPY) SYST	Apr 26, 1989	Substantially Equivalent	S & S X-Ray Products, Inc.
K880047	HUESTIS COMPU-FORMER	Apr 11, 1988	Substantially Equivalent	Huestis Machine Corp.
K860193	PORTALCAST	Jan 30, 1986	Substantially Equivalent	Diacor, Inc.
K852353	DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM	Aug 07, 1985	Substantially Equivalent	Thomson-Cgr Medical Corp.
K842615	CLARK PRECISION BLOCK CUTTER, COOLING	Sep 04, 1984	Substantially Equivalent	Clark Research and Development, Inc.
K791178	MYVACET 5-07, 7-00 AND 9-40	Sep 17, 1979	Substantially Equivalent	Radiation Products Design, Inc.