FDA Registration
Active
🇺🇸 United States
Deep Learning Image Reconstruction
Reg #: 3007545404
·
FEI: 3007545404
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GEXPRO, a Division of REXEL USA, Inc.
- Registration Number
- 3007545404
- FEI Number
- 3007545404
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- W134 N5450 Campbell Drive, Suite 100
- City
- Menomonee Falls
- State
- WI
- ZIP
- 53051
- Country
- US
Regulatory Submissions
- 510(k) Number
- K193170
Owner / Operator
- Firm Name
- Gexpro, A Division of Rexel USA, Inc.
- Operator Number
- 10027980
- Address
- W134 N5450 Campbell Drive, Suite 100
- City
- Menomonee Falls
- State
- WI
- Postal Code
- 53051
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2020-08-11 |
Proprietary Names
Deep Learning Image Reconstruction
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)