GEXPRO, a Division of REXEL USA, Inc.

FDA Device Registration & Listing · Menomonee Falls, WI, US · Registration 3007545404

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007545404
FEI Number
3007545404
Entity Name
GEXPRO, a Division of REXEL USA, Inc.
City/State/Country
Menomonee Falls, WI, US
Establishment Address
W134 N5450 Campbell Drive, Suite 100, Menomonee Falls, WI 53051, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Gexpro, A Division of Rexel USA, Inc. (Owner Number: 10027980)
Owner / Operator Contact Address
W134 N5450 Campbell Drive, Suite 100, Menomonee Falls, WI 53051, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 Deep Learning Image Reconstruction Advantage 4D SmartScore Brainwave PA, Brainwave PA Performance, Brainwave PA Fusion Performance, BrainWave Performance, BrainWave Fusion Perf, B Spectral Bone Marrow

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2017-10-20
KPQ System, Simulation, Radiation Therapy Radiology Class 2 892.5840 2018-03-09
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-08-12
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2020-08-12
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2017-10-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2018-03-09
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2018-03-09
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-03-09
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2018-03-09
KPQ System, Simulation, Radiation Therapy Radiology Class 2 892.5840 2018-03-09
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2021-09-09
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2022-11-28
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2019-07-16
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2018-03-09
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-05-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2018-03-09
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2018-03-09
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2018-03-09
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2023-11-09
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2023-11-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Gexpro, A Division of Rexel USA, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243523 Siemens Medical Solutions USA, Inc. NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime 2025-02-12
K781431 General Electric Co. ELECTRIC CT/T OPERATOR DISPLAY CONSOLE 1978-09-07
K231574 FUJIFILM Healthcare Americas Corporation Scenaria View 4.2 2023-10-12
K233583 FUJIFILM Healthcare Americas Corporation FCT iSTREAM Phase 1 2024-04-26
K151376 Covidien, LLC superDimension Navigation System 2015-11-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2011 GE Medical Systems, LLC 2
HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017 Philips Medical Systems 2
Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017 Philips Medical Systems 2
Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017 Philips Medical Systems 2
Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017 Philips Medical Systems 2
Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007545404. Last updated year: 2026. Please use registration number 3007545404 when referencing this establishment in official correspondence.
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