Identity
- Trade Name
- SW, Legal Labelling Install Disk, 5.1.9 FDA UDI
- Generic Name
- Linear accelerator system FDA UDI
- Device Name
- TomoTherapy Treatment System (H Series) FDA UDI
- Model / Reference
- 1093013 FDA UDI
- Description
- TomoTherapy Treatment System (H Series) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811376030795 FDA UDI
- 510(k) Number
- K121934 FDA UDI
- FDA Product Code
- MUJ FDA UDIIYE 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
No
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
SW, Legal Labelling Install Disk, 5.1.9 by Accuray Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K121934 also covers:
- TomoHDA® Treatment Delivery System — Accuray Incorporated
- TomoHD® Treatment Delivery System — Accuray Incorporated
- TomoH® Treatment Delivery System — Accuray Incorporated
- TomoTherapy Treatment System (Tomo HD™) — Accuray Incorporated
- TomoTherapy® Treatment Delivery System — Accuray Incorporated
- reNEW™ Certified Pre-Owned System — Accuray Incorporated
- reNEW™ Certified Pre-Owned System — Accuray Incorporated
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 2e1c5ffc-5304-4dfd-892a-8e112e9ee5e4 35 fields · synced Jun 9, 2026