Product code IXI— Radiology
.DECIMAL APERTURE
- Classification name
- Block, Beam-Shaping, Radiation Therapy
- Device class
- Class 2
- Regulation
- 21 CFR 892.5710
- Advisory panel
- Radiology
- Total cleared
- 51
- First cleared
- Most recent
Market context for product code IXI
FDA has cleared devices under product code IXI between 1979 and 2026, filed by 36 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2022
- 2013
- 2012
- 2011
- 2009
- 2007
- 2006
- 2004
- 2003
- 2002
- 2001
- 2000
- 1999
- 1998
Top applicants under product code IXI
Recent clearances under product code IXI
- K253025 — Ricoh 3D for Healthcare Bolus
- K222639 — VHA Radiotherapy Bolus
- K214093 — VSP Bolus
- K132236 — .DECIMAL PROTON APERTURE
- K131150 — CURA COMPENSATOR
- K123893 — CURA COLLIMATOR
- K123015 — .DECIMAL PHOTON BLOCK
- K111676 — APEX
- K111759 — .DECIMAL ELECTRON APERTURE
- K091403 — MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY
- K091911 — BOLUS COMPENSATOR
- K090417 — AXXENT FLEXISHIELD MINI
- K071078 — .DECIMAL RANGE COMPENSATOR
- K071077 — .DECIMAL APERTURE
- K062781 — MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY
- K060187 — TOPSLANE DMLC
- K052383 — INNOCURE IMRT FILTER (COMPENSATORS)
- K040804 — .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR
- K040553 — MODIFICATION TO ACCULEAF
- K032790 — MICROMLC
- K030609 — MODULEAF
- K021987 — PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY
- K013875 — MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE
- K011816 — MINI MULTILEAF COLLIMATOR, MODEL KMI
- K010172 — LEAD BLOCKS
- K001163 — DMLC IV-ERGO
- K000349 — MOTORIZED MICRO MULTILEAF COLLIMATOR
- K000137 — ENHANCED COMPENSATING FILTER
- K990491 — ANGIO-CT MIYABI
- K981992 — ELECTRON WEDGE MODEL MT-EW-1000
- K974239 — AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM
- K973953 — AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM
- K972016 — AUTIMO 2.5-D AND AUTIMO 3-D
- K971001 — AUTIMO
- K970303 — SATURNE MULTILEAF COLLIMATOR
- K961902 — SIEMENS BEAM SHAPER
- K954248 — SIEMENS VIRTURAL WEDGE
- K953227 — CASPER
- K953894 — SIEMENS MULTILEAF COLLIMATOR
- K940412 — MULTILEAF INTENSITY MODULATING COLLIMATOR
- K943343 — FIELD ABUTMENT WEDGE
- K941719 — 360 DEG. ROTATING 1/2 BEAM BLOCK
- K904124 — PHILIPS MULTILEAF COLLIMATOR (MLC)
- K901567 — THE HUESTIS COMPU-PLOTTER
- K893464 — VARIAN MULTILEAF COLLIMATOR
- K883317 — DCD-1 (DIGITAL CONTOUR DETECT-RADIAT THERAPY) SYST
- K880047 — HUESTIS COMPU-FORMER
- K860193 — PORTALCAST
- K852353 — DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM
- K842615 — CLARK PRECISION BLOCK CUTTER, COOLING
- K791178 — MYVACET 5-07, 7-00 AND 9-40
Data sourced from openFDA. This site is unofficial and independent of the FDA.