FDA UDI
In Commercial Distribution
🇺🇸 United States
TomoH® Treatment Delivery System
DI: M65810182840
·
Model: 1018284-000
·
ACCURAY INCORPORATED
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TomoH® Treatment Delivery System
- Primary DI
- M65810182840
- Version / Model
- 1018284-000
- Catalog Number
- NA
- Company Name
- ACCURAY INCORPORATED
- Labeler DUNS
- 785961244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 3
- Public Version Date
- 2018-05-22
- Public Version Status
- Update
- Public Device Record Key
- 17a7d1fa-865b-4c19-8850-7a3a8add41d1
Device Description
TomoTherapy® Treatment System (H Series)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
| MUJ | System,Planning,Radiation Therapy Treatment | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35159 | Linear accelerator system | An assembly of devices designed to produce high-energy electrons to yield high-energy x-rays used for therapeutic applications, primarily to treat cancer. It provides a uniform radiation field of uniform intensity and predictable energy level, in a beam with well defined dimensions. The principle of operation is linear acceleration of electrons by means of electromagnetic (EM) microwaves. The output is used as a treatment beam on the patient, either directly or after passing a suitable target. The system typically includes signal analysis and display devices, patient and device supports, and software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M65810182840 | HIBCC |
Customer Contacts
- Phone
- 408-716-4600
- [email protected]