FDA Registration
Active
🇺🇸 United States
GEXPRO, a Division of REXEL USA, Inc.
Reg #: 3007545404
·
FEI: 3007545404
·
Expires 2026
Products
7
Proprietary Names
24
Establishment Types
1
Classifications
7
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Registration Details
- Registration Name
- GEXPRO, a Division of REXEL USA, Inc.
- Registration Number
- 3007545404
- FEI Number
- 3007545404
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- W134 N5450 Campbell Drive, Suite 100
- City
- Menomonee Falls
- State
- WI
- ZIP
- 53051
- Country
- US
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 | 2017-10-20 |
| System, Simulation, Radiation Therapy | KPQ | Class 2 | Radiology | No | 2018-03-09 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2020-08-12 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2018-03-09 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2023-11-09 |
| System, Tomography, Computed, Emission | KPS | Class 2 | Radiology | No | 2018-03-09 |
| Radiological Image Processing Software For Radiation Therapy | QKB | Class 2 | Radiology | No | 2023-09-05 |
Proprietary Names
ASiR-V
AdvantageSim MD with MR pelvic organ at risk segmentation Option
SnapShot Freeze 2
DISCOVERY CT 590 RT; OPTIMA CT 580; OPTIMA CT 580 RT; OPTIMA CT 580 W; Discovery RT; SmartMAR
Volume Viewer 5, OncoQuant, Reporting Tool, Preprocessing Enabler, Volume Viewer, Volume Viewer Apps, Autolaunch, PROV
Volume Viewer 2, Volume Viewer 3.1, Volume Viewer 4, Volume Viewer MR, Volume Viewer PET, Volume Viewer Innova,
CardIQ Xpress Process 2 with Snapshot Freeze option; CardIQ Xpress Reveal; CardIQ Xpress Process; CardIQ Xpress 2
AdvantageSim MD with CT Atlas-based Contouring and Re-planning Options
MaxFOV 2
Deep Learning Image Reconstruction
MAGiC, MAGnetic resonance image Compilation
Dentascan
Advantage 4D
SmartScore
Brainwave PA, Brainwave PA Performance, Brainwave PA Fusion Performance, BrainWave Performance, BrainWave Fusion Perf, B
Spectral Bone Marrow
AdvantageSim MD
MR Pasting 1.1, MR Pasting
cvi42, cvi42_cmr42, cvi42_Mitral
CardiacVX, CardiacVX StarMap, CardiacVX Flow
GSI Viewer with VUE Option ; GSI MSI; GSI Viewer; GSI Volume Viewer
CortexID Suite
Deep Learning Auto Segmentation
Optima 560, Discovery PET/CT, Optima PET/CT
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)