Identity
- Trade Name
- .decimal Photon Compensator FDA UDI
- Generic Name
- Radiation therapy beam block material FDA UDI
- Device Name
- A custom manufactured solid filters for missing tissue and intensity modulation for external beam radiation therapy. FDA UDI
- Model / Reference
- 1.0 FDA UDI
- Description
- A custom manufactured solid filters for missing tissue and intensity modulation for external beam radiation therapy. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851147007052 FDA UDI
- 510(k) Number
- K040804 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
.decimal Photon Compensator by .Decimal, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 62925013-c305-49ed-a4a5-770586adee2a 35 fields · synced May 30, 2026