Identity
- Trade Name
- Radixact®, Treatment Delivery Console FDA UDI
- Generic Name
- Linear accelerator system FDA UDI
- Device Name
- Software, Version 1.0.0.2, Treatment Delivery Console, Radixact Version 1.0.0.2 (Operating Software for Radixact Treatment Delivery System) FDA UDI
- Model / Reference
- 1055487 FDA UDI
- Description
- Software, Version 1.0.0.2, Treatment Delivery Console, Radixact Version 1.0.0.2 (Operating Software for Radixact Treatment Delivery System) FDA UDI
Identifiers
- Catalog Number
- NA FDA UDI
- Primary DI / UDI-DI
- M65810554870 FDA UDI
- FDA Product Code
- IYE 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 system
Radixact®, Treatment Delivery Console by Accuray Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Linear accelerator system.
- Clinac iX — Varian Medical Systems, Inc · Class II
- LIAC — Sit Sordina Iort Technologies Spa · Class II
- Head Coil (Receive Only) — VIEWRAY INCORPORATED · Class II
- Elekta Unity — Elekta Inc. · Class II
- Varian Collimator Accessories 30 CM wedge set upper (JITKIT) — Varian Medical Systems, Inc · Class II
- Elekta Unity — Elekta Inc. · Class II
- Elekta Unity — Elekta Inc. · Class II
- VitalBeam — Varian Medical Systems, Inc · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Accuray Incorporated
Sources (1)
- FDA UDI 5926edd9-03bd-449c-80f0-6465a71b42de 35 fields · synced Jun 9, 2026