FDA Registration
Active
🇺🇸 United States
IrisVision Inspire
Reg #: 3014397047
·
FEI: 3014397047
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- RadiusXR Inc.
- Registration Number
- 3014397047
- FEI Number
- 3014397047
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5994 W LAS POSITAS BLVD STE 101
- City
- Pleasanton
- State
- CA
- ZIP
- 94588
- Country
- US
Owner / Operator
- Firm Name
- RadiusXR, Inc.
- Operator Number
- 10049603
- Address
- 5994 W. Las Positas Blvd, Suite 101
- City
- Pleasanton
- State
- CA
- Postal Code
- 94588
- Country
- US
- Correspondent
- John Trefethen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Aid, Vision Image Intensification | HOT | Class 1 | Ophthalmic | No | 2015-06-26 |
Proprietary Names
IrisVision Inspire
IrisVision Live
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198