IXI · Class II · 21 CFR 892.5710

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

Leading manufacturers include .Decimal, Inc., Siemens Medical Solutions USA, Inc. and Aktina Medical Physics Corp..

51
Total
51
Cleared
108d
Avg days
1979
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
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 29, 2009
MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY
K091403
Oncology Tech, LLC
Radiology · 78d
Cleared Jul 21, 2009
BOLUS COMPENSATOR
K091911
.Decimal, Inc.
Radiology · 26d
Cleared Jun 23, 2009
AXXENT FLEXISHIELD MINI
K090417
Xoft, Inc.
Radiology · 125d
Cleared May 22, 2007
.DECIMAL RANGE COMPENSATOR
K071078
.Decimal, Inc.
Radiology · 35d
Cleared May 18, 2007
.DECIMAL APERTURE
K071077
.Decimal, Inc.
Radiology · 31d
Cleared Nov 21, 2006
MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY
K062781
Symtium Corporation
Radiology · 64d
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 28, 2004
.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR
K040804
Southeastern Radiation Products, Inc.
Radiology · 30d
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 Mar 17, 2003
MODULEAF
K030609
Mrc Systems GmbH
Radiology · 19d
Cleared Dec 27, 2002
PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY
K021987
S&S Par Scientific
Radiology · 192d
Cleared Sep 27, 2002
MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE
K013875
Med-Tec,Inc.
Radiology · 308d
Cleared Sep 07, 2001
MINI MULTILEAF COLLIMATOR, MODEL KMI
K011816
Mrc Systems GmbH
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 increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

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 →