Home › Device types › IXI
Block, Beam-Shaping, Radiation Therapy
FDA product code IXI · Class 2 · Radiology
27
Registered devices
38
Adverse events
6
Recalls
51
510(k) clearances
Devices with this code
VHA Radiotherapy Bolus — VHA Office of Advanced Manufacturing - Ft. LawtonE-Beam Shaping System — Aktina Corp.Beam Block Set, High Energy — Aktina Corp..decimal Photon Compensator — DECIMAL, INC.Universal Leveling Plate System, Elekta Compatible — Aktina Corp..decimal Proton Aperture — DECIMAL, INC.Electron Beam Shaping Full System, Siemens 95 cm, Full System — Aktina Corp.decimal Bolus (FlexiBol) — DECIMAL, INC.Apex™ — ELEKTA LIMITED.decimal Electron Aperture — DECIMAL, INC.Universal Leveling Template, 25X25 — Aktina Corp.Hot Wire Cutter — Aktina Corp.Universal Leveling Template, 10X10 — Aktina Corp.Universal Leveling Template, 20X20 — Aktina Corp.Universal Leveling Template, Set of Five — Aktina Corp.Beam Block Set, Low Energy — Aktina Corp..decimal Proton Range Compensator — DECIMAL, INC.Universal Leveling Template, 6X6 — Aktina Corp.Electron Beam Shaping System, Elekta Compatible, Full System — Aktina Corp.Universal Leveling Template, 10X10 — Aktina Corp.Low Energy Beam Block Set — Aktina Corp.Universal Leveling Template, 14X14 — Aktina Corp.VSP Bolus — 3D SYSTEMS, INC.High Energy Beam Block Set — Aktina Corp.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-08-15 | Elekta, Inc. | Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect. |
| 2013-05-01 | Elekta, Inc. | It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems |
| 2013-01-18 | Elekta, Inc. | If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 re |
| 2012-02-07 | Siemens Medical Solutions USA, Inc | This correction is being performed to update the safety knob of the Siemens brand mMLC (ModuLeaf) to conform to tie IEC 60601-1 safety standard. |
| 2011-02-03 | Xoft Inc. | Xoft Axxent Flexishield Mini product may may shed particles identified as tungsten, and may look like suspicious calcifications on follow up scans if the produc |
| 2008-03-14 | Philips Medical Systems North America Co. Phillips | Potential for radiologic patient table to become immobile and unable to move again due to force sensor sensitivity to electromagnetic radiation. |
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