IXI — Block, Beam-Shaping, Radiation Therapy Class II
FDA product code IXI covers "Block, Beam-Shaping, Radiation Therapy", a Class II medical device regulated under 21 CFR 892.5710. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IXI
- Device Class
- Class II
- Regulation Number
- 892.5710
- Submission Type
- 510(k)
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253025 | Ricoh 3D For Healthcare | Ricoh 3D for Healthcare Bolus | Apr 6, 2026 |
| K222639 | Vha Dean | VHA Radiotherapy Bolus | Nov 4, 2022 |
| K214093 | 3D Systems | VSP Bolus | Mar 30, 2022 |
| K132236 | .Decimal | .DECIMAL PROTON APERTURE | Oct 16, 2013 |
| K131150 | Cura Medical Technologies | CURA COMPENSATOR | Jul 30, 2013 |
| K123893 | Cura Medical Technologies | CURA COLLIMATOR | Mar 4, 2013 |
| K123015 | .Decimal | .DECIMAL PHOTON BLOCK | Nov 21, 2012 |
| K111676 | Elekta Limited | APEX | Sep 30, 2011 |
| K111759 | .Decimal | .DECIMAL ELECTRON APERTURE | Sep 9, 2011 |
| K091403 | Oncology Tech | MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY | Jul 29, 2009 |
| K091911 | .Decimal | BOLUS COMPENSATOR | Jul 21, 2009 |
| K090417 | Xoft | AXXENT FLEXISHIELD MINI | Jun 23, 2009 |
| K071078 | .Decimal | .DECIMAL RANGE COMPENSATOR | May 22, 2007 |
| K071077 | .Decimal | .DECIMAL APERTURE | May 18, 2007 |
| K062781 | Symtium Corporation | MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY | Nov 21, 2006 |
| K060187 | Topslane International | TOPSLANE DMLC | Jul 27, 2006 |
| K052383 | Innocure | INNOCURE IMRT FILTER (COMPENSATORS) | Mar 29, 2006 |
| K040804 | Southeastern Radiation Products | .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR | Apr 28, 2004 |
| K040553 | Direx Systems | MODIFICATION TO ACCULEAF | Apr 1, 2004 |
| K032790 | Siemens Medical Solutions Usa | MICROMLC | Oct 2, 2003 |