Identity
- Trade Name
- Accuray Precision® Treatment Planning System FDA UDI
- Generic Name
- Linear accelerator system FDA UDI
- Device Name
- Software, Version 1.0, Precision Treatment Planning System The Accuray Precision Treatment Planning System is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery. FDA UDI
- Model / Reference
- 1050242 FDA UDI
- Description
- Software, Version 1.0, Precision Treatment Planning System The Accuray Precision Treatment Planning System is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery. FDA UDI
Identifiers
- Catalog Number
- NA FDA UDI
- Primary DI / UDI-DI
- M65810502420 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
- 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
Yes
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
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 7c7e2f0d-c211-4ffc-9452-dc23c244b678 35 fields · synced Jun 9, 2026