Identity
- Trade Name
- Onrad Treatment System FDA UDI
- Generic Name
- Linear accelerator system FDA UDI
- Device Name
- The Onrad™ Treatment System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT imaging for IGRT functionality, and fixed beam (non-rotational) radiation therapy treatment capabilities into a single comprehensive system. The Onrad™ Treatment System is a prescription device. It delivers radiation in accordance with a physician approved plan. The device does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality is not intended for diagnostic use. FDA UDI
- Model / Reference
- 1049211 FDA UDI
- Description
- The Onrad™ Treatment System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT imaging for IGRT functionality, and fixed beam (non-rotational) radiation therapy treatment capabilities into a single comprehensive system. The Onrad™ Treatment System is a prescription device. It delivers radiation in accordance with a physician approved plan. The device does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality is not intended for diagnostic use. FDA UDI
Identifiers
- Catalog Number
- NA FDA UDI
- Primary DI / UDI-DI
- M65810492110 FDA UDI
- 510(k) Number
- K152488 FDA UDI
- FDA Product Code
- MUJ FDA UDI
- GMDN Term
- Linear accelerator system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Onrad Treatment System by Accuray Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Accuray Incorporated
Sources (1)
- FDA UDI c8249a23-0cfe-4bd2-9aed-ddf436912f9b 37 fields · synced Jun 9, 2026