Product code IXI
- Device name
- Block, Beam-Shaping, Radiation Therapy
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.5710
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253025 | Ricoh 3D for Healthcare Bolus | Ricoh 3D For Healthcare, LLC | 2026-04-06 |
| K222639 | VHA Radiotherapy Bolus | Vha Dean | 2022-11-04 |
| K214093 | VSP Bolus | 3D Systems | 2022-03-30 |
| K132236 | .DECIMAL PROTON APERTURE | .Decimal, Inc. | 2013-10-16 |
| K131150 | CURA COMPENSATOR | Cura Medical Technologies, LLC | 2013-07-30 |
| K123893 | CURA COLLIMATOR | Cura Medical Technologies, LLC | 2013-03-04 |
| K123015 | .DECIMAL PHOTON BLOCK | .Decimal, Inc. | 2012-11-21 |
| K111676 | APEX | Elekta Limited | 2011-09-30 |
| K111759 | .DECIMAL ELECTRON APERTURE | .Decimal, Inc. | 2011-09-09 |
| K091403 | MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY | Oncology Tech, LLC | 2009-07-29 |
| K091911 | BOLUS COMPENSATOR | .Decimal, Inc. | 2009-07-21 |
| K090417 | AXXENT FLEXISHIELD MINI | Xoft, Inc. | 2009-06-23 |
| K071078 | .DECIMAL RANGE COMPENSATOR | .Decimal, Inc. | 2007-05-22 |
| K071077 | .DECIMAL APERTURE | .Decimal, Inc. | 2007-05-18 |
| K062781 | MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY | Symtium Corporation | 2006-11-21 |
| K060187 | TOPSLANE DMLC | Topslane International, LLC | 2006-07-27 |
| K052383 | INNOCURE IMRT FILTER (COMPENSATORS) | Innocure, LLC | 2006-03-29 |
| K040804 | .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR | Southeastern Radiation Products, Inc. | 2004-04-28 |
| K040553 | MODIFICATION TO ACCULEAF | Direx Systems Corp. | 2004-04-01 |
| K032790 | MICROMLC | Siemens Medical Solutions USA, Inc. | 2003-10-02 |
| K030609 | MODULEAF | Mrc Systems GmbH | 2003-03-17 |
| K021987 | PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY | S&S Par Scientific | 2002-12-27 |
| K013875 | MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE | Med-Tec,Inc. | 2002-09-27 |
| K011816 | MINI MULTILEAF COLLIMATOR, MODEL KMI | Mrc Systems GmbH | 2001-09-07 |
| K010172 | LEAD BLOCKS | Arplay Medical S.A. | 2001-04-18 |
| K001163 | DMLC IV-ERGO | 3D Line USA, Inc. | 2000-10-23 |
| K000349 | MOTORIZED MICRO MULTILEAF COLLIMATOR | Stryker Leibinger | 2000-05-03 |
| K000137 | ENHANCED COMPENSATING FILTER | Computerized Medical Systems, Inc. | 2000-04-17 |
| K990491 | ANGIO-CT MIYABI | Siemens Medical Solutions USA, Inc. | 1999-04-05 |
| K981992 | ELECTRON WEDGE MODEL MT-EW-1000 | Med-Tec,Inc. | 1998-12-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G003BL010 | 3D Bolus | Ricoh Usa, Inc. | 2026-05-27 |
| 00850038561048 | VHA Radiotherapy Bolus | VHA Office of Advanced Manufacturing - Ft. Lawton | 2025-12-02 |
| 00816847022613 | VSP Bolus | 3D SYSTEMS, INC. | 2023-02-07 |
| 00851147007137 | decimal Bolus (FlexiBol) | DECIMAL, INC. | 2022-12-01 |
| B365112680 | Universal Leveling Template, Set of Five | Aktina Corp. | 2021-05-21 |
| B365112690 | Universal Leveling Plate System, Elekta Compatible | Aktina Corp. | 2021-05-21 |
| B365530460 | Hot Wire Cutter | Aktina Corp. | 2021-05-21 |
| B36511268030 | Universal Leveling Template, 14X14 | Aktina Corp. | 2016-09-27 |
| B36511268040 | Universal Leveling Template, 10X10 | Aktina Corp. | 2016-09-27 |
| B36511268020 | Universal Leveling Template, 20X20 | Aktina Corp. | 2016-09-27 |
| B36511268010 | Universal Leveling Template, 25X25 | Aktina Corp. | 2016-09-27 |
| 00851147007052 | .decimal Photon Compensator | DECIMAL, INC. | 2016-09-24 |
| 00851147007045 | .decimal Photon Block | DECIMAL, INC. | 2016-09-24 |
| 00851147007038 | .decimal Electron Aperture | DECIMAL, INC. | 2016-09-24 |
| 00851147007021 | .decimal Electron Bolus | DECIMAL, INC. | 2016-09-24 |
| 00851147007014 | .decimal Proton Range Compensator | DECIMAL, INC. | 2016-09-24 |
| 05060191071215 | Apex™ | ELEKTA LIMITED | 2016-09-24 |
| B365534260 | Beam Block Set, High Energy | Aktina Corp. | 2016-09-24 |
| B365534180 | Beam Block Set, Low Energy | Aktina Corp. | 2016-09-24 |
| B365526260 | E-Beam Shaping System | Aktina Corp. | 2016-09-24 |
| B365524850 | Electron Beam Shaping Full System, Siemens 95 cm, Full System | Aktina Corp. | 2016-09-24 |
| B365112900 | High Energy Beam Block Set | Aktina Corp. | 2016-09-24 |
| B365112850 | Low Energy Beam Block Set | Aktina Corp. | 2016-09-24 |
| B365112700 | Electron Beam Shaping System, Elekta Compatible, Full System | Aktina Corp. | 2016-09-24 |
| B36511269020 | Universal Leveling Template, 6X10 | Aktina Corp. | 2016-09-24 |
| B36511269010 | Universal Leveling Template, 10X10 | Aktina Corp. | 2016-09-24 |
| B36511268050 | Universal Leveling Template, 6X6 | Aktina Corp. | 2016-09-24 |
| 00851147007007 | .decimal Proton Aperture | DECIMAL, INC. | 2016-09-23 |