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
- 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 | April 6, 2026 |
| K222639 | vha dean | VHA Radiotherapy Bolus | November 4, 2022 |
| K214093 | 3d systems | VSP Bolus | March 30, 2022 |
| K132236 | .decimal | .DECIMAL PROTON APERTURE | October 16, 2013 |
| K131150 | cura medical technologies | CURA COMPENSATOR | July 30, 2013 |
| K123893 | cura medical technologies | CURA COLLIMATOR | March 4, 2013 |
| K123015 | .decimal | .DECIMAL PHOTON BLOCK | November 21, 2012 |
| K111676 | elekta limited | APEX | September 30, 2011 |
| K111759 | .decimal | .DECIMAL ELECTRON APERTURE | September 9, 2011 |
| K091403 | oncology tech | MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY | July 29, 2009 |
| K091911 | .decimal | BOLUS COMPENSATOR | July 21, 2009 |
| K090417 | xoft | AXXENT FLEXISHIELD MINI | June 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 | November 21, 2006 |
| K060187 | topslane international | TOPSLANE DMLC | July 27, 2006 |
| K052383 | innocure | INNOCURE IMRT FILTER (COMPENSATORS) | March 29, 2006 |
| K040804 | southeastern radiation products | .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR | April 28, 2004 |
| K040553 | direx systems | MODIFICATION TO ACCULEAF | April 1, 2004 |
| K032790 | siemens medical solutions usa | MICROMLC | October 2, 2003 |