Identity
- Trade Name
- .decimal Electron Bolus FDA UDI
- Generic Name
- Radiation therapy beam block material FDA UDI
- Device Name
- A custom manufactured solid Bolus Compensators for intensity modulation of external beam radiation therapy. FDA UDI
- Model / Reference
- 1.0 FDA UDI
- Description
- A custom manufactured solid Bolus Compensators for intensity modulation of external beam radiation therapy. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851147007021 FDA UDI
- 510(k) Number
- K091911 FDA UDI
- FDA Product Code
- IXI FDA UDI
- GMDN Term
- Radiation therapy beam block material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5710 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiation therapy beam block material
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.
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Also classified as Radiation therapy beam block material.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- .Decimal, LLC
Sources (1)
- FDA UDI 2b1d3ef1-9cbd-4de3-85cf-dfc98b080778 35 fields · synced Jul 30, 2026