FDA UDI
In Commercial Distribution
🇺🇸 United States
TomoTherapy Treatment Delivery System with iDMS
DI: M65810682830
·
Model: 1068283
·
ACCURAY INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TomoTherapy Treatment Delivery System with iDMS
- Primary DI
- M65810682830
- Version / Model
- 1068283
- 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
- 2018-11-02
- Public Version
- 1
- Public Version Date
- 2018-12-03
- Public Version Status
- New
- Public Device Record Key
- ae7422a3-c3ad-4f87-bf87-6416a0fe76d6
Device Description
The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.
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 |
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 | M65810682830 | HIBCC |
Customer Contacts
- Phone
- 408-716-4600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171837 | 000 |