Identity
- Trade Name
- Delivery Analysis TM FDA UDI
- Generic Name
- Linear accelerator system FDA UDI
- Device Name
- Software, Delivery Analysis, Version 1.2 FDA UDI
- Model / Reference
- 1057375 FDA UDI
- Description
- Software, Delivery Analysis, Version 1.2 FDA UDI
Identifiers
- Catalog Number
- NA FDA UDI
- Primary DI / UDI-DI
- M65810573750 FDA UDI
- 510(k) Number
- K143269 FDA UDI
- FDA Product Code
- IYE FDA UDIMUJ 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Linear accelerator system
Delivery Analysis TM 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
Cleared under the same submission
K143269 also covers:
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 5e9e85d6-0212-4dc3-9349-518a0ebcd383 36 fields · synced Jun 9, 2026