IXI · Block, Beam-Shaping, Radiation Therapy
Radiology · 21 CFR 892.5710 · Class 2
Overview
| Product Code | IXI |
|---|---|
| Device Name | Block, Beam-Shaping, Radiation Therapy |
| Regulation | 21 CFR 892.5710 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 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 | Ricoh 3D for Healthcare Bolus | Ricoh 3D For Healthcare, LLC | Apr 6, 2026 | SESE |
| K222639 | VHA Radiotherapy Bolus | Vha Dean | Nov 4, 2022 | SESE |
| K214093 | VSP Bolus | 3D Systems | Mar 30, 2022 | SESE |
| K132236 | .DECIMAL PROTON APERTURE | .Decimal, Inc. | Oct 16, 2013 | SESE |
| K131150 | CURA COMPENSATOR | Cura Medical Technologies, LLC | Jul 30, 2013 | SESE |
| K123893 | CURA COLLIMATOR | Cura Medical Technologies, LLC | Mar 4, 2013 | SESE |
| K123015 | .DECIMAL PHOTON BLOCK | .Decimal, Inc. | Nov 21, 2012 | SESE |
| K111676 | APEX | Elekta Limited | Sep 30, 2011 | SESE |
| K111759 | .DECIMAL ELECTRON APERTURE | .Decimal, Inc. | Sep 9, 2011 | SESE |
| K091403 | MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY | Oncology Tech, LLC | Jul 29, 2009 | SESE |
| K091911 | BOLUS COMPENSATOR | .Decimal, Inc. | Jul 21, 2009 | SESE |
| K090417 | AXXENT FLEXISHIELD MINI | Xoft, Inc. | Jun 23, 2009 | SESE |
| K071078 | .DECIMAL RANGE COMPENSATOR | .Decimal, Inc. | May 22, 2007 | SESE |
| K071077 | .DECIMAL APERTURE | .Decimal, Inc. | May 18, 2007 | SESE |
| K062781 | MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY | Symtium Corporation | Nov 21, 2006 | SESE |
| K060187 | TOPSLANE DMLC | Topslane International, LLC | Jul 27, 2006 | SESE |
| K052383 | INNOCURE IMRT FILTER (COMPENSATORS) | Innocure, LLC | Mar 29, 2006 | SESE |
| K040804 | .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR | Southeastern Radiation Products, Inc. | Apr 28, 2004 | SESE |
| K040553 | MODIFICATION TO ACCULEAF | Direx Systems Corp. | Apr 1, 2004 | SESE |
| K032790 | 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
