.decimal Electron Bolus 1.0
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Overview
The decimal Electron Bolus is a custom-manufactured solid bolus compensator designed for intensity modulation of external beam radiation therapy. This device is used to shape and control the depth of penetration of the radiation beam, reducing exposure to non-target areas.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00851147007021 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK091911 | Date21 Jul 2009 | StatusActive |
Official records
- AccessGUDID record 00851147007021
- FDA 510(k) database K091911
Across registries
- FDA 510(k) K091911 decided 21 Jul 2009 Active
- FDA GUDID UDI-DI 00851147007021 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K091911
- Listed FDA GUDID 00851147007021
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- .decimal Electron Bolus
- Generic name
- Radiation therapy beam block material
- Model / reference
- 1.0
- Primary DI / UDI-DI
- 00851147007021
- 510(k) Number
- FDA product code
- IXI
- GMDN term
- Radiation therapy beam block material
- Device class
- Class II
- Regulation number
- 892.5710
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code IXI (Block, Beam-Shaping, Radiation Therapy).
- Autimo 2.5-D and Autimo 3-D by C.L. Mcintosh & Assoc., Inc.
- Aktina Medical Physics Corporation Photon Beam Blocking System by Aktina Medical Physics Corp.
- Enhanced Compensating Filter by Computerized Medical Systems, Inc.
- Decimal Tissue Compensator/Intensity Modulator by Southeastern Radiation Products, Inc.
- AUTIMO by Medizintechnik, GmbH
- HUESTIS COMPU-FORMER by HUESTIS MACHINE CORP.
- CLARK PRECISION BLOCK CUTTER, COOLING by Clark Research and Development, Inc.
- MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE by Medtec LLC
- SIEMENS BEAM SHAPER by SIEMENS MEDICAL SOLUTIONS USA, INC.
- TOPSLANE DMLC by Topslane International, LLC