FDA Registration
Active
🇺🇸 United States
Radixact Treatment Delivery System, Accuray Helix (A configuration of Radixact Treatment Delivery System)
Reg #: 3003873069
·
FEI: 3003873069
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Accuray Incorporated
- Registration Number
- 3003873069
- FEI Number
- 3003873069
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1209 DEMING WAY
- City
- MADISON
- State
- WI
- ZIP
- 53717
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223159
Owner / Operator
- Firm Name
- Accuray Incorporated
- Operator Number
- 9005157
- Address
- 1209 Deming Way, --
- City
- Madison
- State
- WI
- Postal Code
- 53717
- Country
- US
- Correspondent
- Daniel Biank
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2023-06-27 |
Proprietary Names
Radixact Treatment Delivery System, Accuray Helix (A configuration of Radixact Treatment Delivery System)
Establishment Types
Manufacture Medical Device