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 Aperture is designed by the customer to block and shape a beam of radiation. Each aperture is patient specific and for single use. FDA UDI
- Model / Reference
- 18cm Brass 360 Aperture FDA UDI
- Description
- Proton Systems Radiation Therapy Beam-Shaping Aperture is designed by the customer to block and shape a beam of radiation. Each aperture is patient specific and for single use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00861206000337 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 11adc493-96e1-4067-927f-958b2fdc867e 34 fields · synced May 30, 2026