Identity
- Trade Name
- Accuray Precision® Treatment Planning System FDA UDI
- Generic Name
- Radiation therapy treatment planning computer FDA UDI
- Device Name
- Software, Version 2.0, Accuray Precision Treatment Planning System The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems. FDA UDI
- Model / Reference
- 1064270 FDA UDI
- Description
- Software, Version 2.0, Accuray Precision Treatment Planning System The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems. FDA UDI
Identifiers
- Catalog Number
- NA FDA UDI
- Primary DI / UDI-DI
- M65810642700 FDA UDI
- 510(k) Number
- K171086 FDA UDI
- FDA Product Code
- MUJ FDA UDI
- GMDN Term
- Radiation therapy treatment planning computer 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Linear accelerator systemRadiation therapy treatment planning computer
Accuray Precision® Treatment Planning System by Accuray Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiation therapy treatment planning computer.
- Accuray Precision® Treatment Planning System — Accuray Incorporated · Class II
- Accuray Precision® Treatment Planning System — Accuray Incorporated · Class II
- Accuray Precision® Treatment Planning System — Accuray Incorporated · Class II
- Accuray Precision® Treatment Planning System — Accuray Incorporated · Class II
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
- Accuray Incorporated
Sources (1)
- FDA UDI 6dc016b0-1ee3-4fdf-a286-42bd582d6319 36 fields · synced Jun 9, 2026