Identity
- Trade Name
- Proton Systems, LLC FDA UDI
- Generic Name
- Radiation therapy beam block material FDA UDI
- Device Name
- Proton Systems Radiation Therapy Beam Shaping Range Compensator is custom manufactured and designed by the customer for intensity modulation of external beam proton radiation therapy. Each Compensator is patient specific and for single use FDA UDI
- Model / Reference
- 25cm Wax Range Compensator FDA UDI
- Description
- Proton Systems Radiation Therapy Beam Shaping Range Compensator is custom manufactured and designed by the customer for intensity modulation of external beam proton radiation therapy. Each Compensator is patient specific and for single use FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00861206000368 FDA UDI
- 510(k) Number
- K121657 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiation therapy beam block material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiation therapy beam block material
Proton Systems, LLC by Proton Systems Virginia Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Proton Systems Virginia Llc
Sources (1)
- FDA UDI 926bc313-0f6b-44a7-be36-f841de5dd360 34 fields · synced May 31, 2026