Identity
- Trade Name
- Accuray Precision Treatment Planning System FDA UDI
- Generic Name
- Radiation therapy treatment planning workstation FDA UDI
- Device Name
- Accuray Precision™ Treatment Planning System (Version 3.1) FDA UDI
- Model / Reference
- 1070891 FDA UDI
- Description
- Accuray Precision™ Treatment Planning System (Version 3.1) FDA UDI
Identifiers
- Catalog Number
- NA FDA UDI
- Primary DI / UDI-DI
- 00811376030146 FDA UDI
- 510(k) Number
- K171086 FDA UDI
- FDA Product Code
- MUJ FDA UDIIYE FDA UDI
- GMDN Term
- Radiation therapy treatment planning workstation 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: Radiation therapy treatment planning workstation
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 workstation.
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 df195cad-8987-4c64-a0f1-2b67b760a8e7 36 fields · synced Jun 9, 2026