IXI · Class II · 21 CFR 892.5710

FDA Product Code IXI: Block, Beam-shaping, Radiation Therapy

Leading manufacturers include Siemens Medical Solutions USA, Inc., .Decimal, Inc. and Medtec, Inc..

51
Total
51
Cleared
108d
Avg days
1979
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 199d recently vs 106d historically

FDA 510(k) Cleared Block, Beam-shaping, Radiation Therapy Devices (Product Code IXI)

51 devices
1–24 of 51
Cleared Apr 06, 2026
Ricoh 3D for Healthcare Bolus
K253025
Ricoh 3D For Healthcare, LLC
Radiology · 199d
Cleared Nov 04, 2022
VHA Radiotherapy Bolus
K222639
Vha Dean
Radiology · 64d
Cleared Mar 30, 2022
VSP Bolus
K214093
3D Systems
Radiology · 92d
Cleared Oct 16, 2013
.DECIMAL PROTON APERTURE
K132236
.Decimal, Inc.
Radiology · 90d
Cleared Jul 30, 2013
CURA COMPENSATOR
K131150
Cura Medical Technologies, LLC
Radiology · 98d
Cleared Mar 04, 2013
CURA COLLIMATOR
K123893
Cura Medical Technologies, LLC
Radiology · 76d
Cleared Nov 21, 2012
.DECIMAL PHOTON BLOCK
K123015
.Decimal, Inc.
Radiology · 54d
Cleared Sep 30, 2011
APEX
K111676
Elekta Limited
Radiology · 107d
Cleared Sep 09, 2011
.DECIMAL ELECTRON APERTURE
K111759
.Decimal, Inc.
Radiology · 79d
Cleared Jul 27, 2006
TOPSLANE DMLC
K060187
Topslane International, LLC
Radiology · 184d
Cleared Mar 29, 2006
INNOCURE IMRT FILTER (COMPENSATORS)
K052383
Innocure, LLC
Radiology · 211d
Cleared Apr 01, 2004
MODIFICATION TO ACCULEAF
K040553
Direx Systems Corp.
Radiology · 30d
Cleared Oct 02, 2003
MICROMLC
K032790
Siemens Medical Solutions USA, Inc.
Radiology · 24d
Cleared Apr 17, 2000
ENHANCED COMPENSATING FILTER
K000137
Computerized Medical Systems, Inc.
Radiology · 90d
Cleared Apr 05, 1999
ANGIO-CT MIYABI
K990491
Siemens Medical Solutions USA, Inc.
Radiology · 47d
Cleared Dec 15, 1998
ELECTRON WEDGE MODEL MT-EW-1000
K981992
Med-Tec,Inc.
Radiology · 190d
Cleared Feb 10, 1998
AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM
K974239
Aktina Medical Physics Corp.
Radiology · 90d
Cleared Jan 14, 1998
AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM
K973953
Aktina Medical Physics Corp.
Radiology · 90d
Cleared Dec 04, 1997
AUTIMO 2.5-D AND AUTIMO 3-D
K972016
C.L. Mcintosh & Assoc., Inc.
Radiology · 188d
Cleared Jun 13, 1997
AUTIMO
K971001
Medizintechnik, GmbH
Radiology · 86d
Cleared Apr 25, 1997
SATURNE MULTILEAF COLLIMATOR
K970303
General Electric Co.
Radiology · 88d
Cleared Aug 08, 1996
SIEMENS BEAM SHAPER
K961902
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Jan 05, 1996
SIEMENS VIRTURAL WEDGE
K954248
Siemens Medical Solutions USA, Inc.
Radiology · 116d
Cleared Nov 13, 1995
SIEMENS MULTILEAF COLLIMATOR
K953894
Siemens Medical Solutions USA, Inc.
Radiology · 88d

About Product Code IXI - Regulatory Context

510(k) Submission Activity

51 total 510(k) submissions under product code IXI since 1979, with 51 receiving FDA clearance (average review time: 108 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - IXI Product Code

Recent submissions under IXI have taken an average of 199 days to reach a decision - up from 106 days historically. Manufacturers should account for longer review timelines in current project planning.

IXI devices are reviewed by the Radiology panel. Browse all Radiology devices →