Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart F — Therapeutic Devices](/submissions/RA/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 892.5710](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5710) → IXI — Block, Beam-Shaping, Radiation Therapy # IXI · Block, Beam-Shaping, Radiation Therapy _Radiology · 21 CFR 892.5710 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI ## Overview - **Product Code:** IXI - **Device Name:** Block, Beam-Shaping, Radiation Therapy - **Regulation:** [21 CFR 892.5710](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5710) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) - **3rd-party reviewable:** yes ## Identification A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 51) Showing 20 most recent of 51 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253025](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K253025.md) | Ricoh 3D for Healthcare Bolus | Ricoh 3D For Healthcare, LLC | Apr 6, 2026 | SESE | | [K222639](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K222639.md) | VHA Radiotherapy Bolus | Vha Dean | Nov 4, 2022 | SESE | | [K214093](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K214093.md) | VSP Bolus | 3D Systems | Mar 30, 2022 | SESE | | [K132236](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K132236.md) | .DECIMAL PROTON APERTURE | .Decimal, Inc. | Oct 16, 2013 | SESE | | [K131150](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K131150.md) | CURA COMPENSATOR | Cura Medical Technologies, LLC | Jul 30, 2013 | SESE | | [K123893](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K123893.md) | CURA COLLIMATOR | Cura Medical Technologies, LLC | Mar 4, 2013 | SESE | | [K123015](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K123015.md) | .DECIMAL PHOTON BLOCK | .Decimal, Inc. | Nov 21, 2012 | SESE | | [K111676](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K111676.md) | APEX | Elekta Limited | Sep 30, 2011 | SESE | | [K111759](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K111759.md) | .DECIMAL ELECTRON APERTURE | .Decimal, Inc. | Sep 9, 2011 | SESE | | [K091403](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K091403.md) | MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY | Oncology Tech, LLC | Jul 29, 2009 | SESE | | [K091911](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K091911.md) | BOLUS COMPENSATOR | .Decimal, Inc. | Jul 21, 2009 | SESE | | [K090417](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K090417.md) | AXXENT FLEXISHIELD MINI | Xoft, Inc. | Jun 23, 2009 | SESE | | [K071078](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K071078.md) | .DECIMAL RANGE COMPENSATOR | .Decimal, Inc. | May 22, 2007 | SESE | | [K071077](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K071077.md) | .DECIMAL APERTURE | .Decimal, Inc. | May 18, 2007 | SESE | | [K062781](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K062781.md) | MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY | Symtium Corporation | Nov 21, 2006 | SESE | | [K060187](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K060187.md) | TOPSLANE DMLC | Topslane International, LLC | Jul 27, 2006 | SESE | | [K052383](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K052383.md) | INNOCURE IMRT FILTER (COMPENSATORS) | Innocure, LLC | Mar 29, 2006 | SESE | | [K040804](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K040804.md) | .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR | Southeastern Radiation Products, Inc. | Apr 28, 2004 | SESE | | [K040553](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K040553.md) | MODIFICATION TO ACCULEAF | Direx Systems Corp. | Apr 1, 2004 | SESE | | [K032790](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K032790.md) | MICROMLC | Siemens Medical Solutions USA, Inc. | Oct 2, 2003 | SESE | ## Top Applicants - .Decimal, Inc. — 6 clearances - Siemens Medical Solutions USA, Inc. — 5 clearances - Aktina Medical Physics Corp. — 2 clearances - Cura Medical Technologies, LLC — 2 clearances - Huestis Machine Corp. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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