Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2126677

FEI Number

2126677

Entity Name

GE MEDICAL SYSTEMS, LLC

City/State/Country

Waukesha, WI, US

Establishment Address

3000 N GRANDVIEW BLVD., Waukesha, WI 53188, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

GE HealthCare Technologies Inc. (Owner Number: 9912004)

Owner / Operator Contact Address

3000 N. Grandview Blvd, Waukesha, WI 53188, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133705

PMA Number

N/A

All Registered Proprietary Names

Optima XR240amx Max Elite Omni Legend Max Apollo Discovery VCT-RX Discovery VCT Discovery RX VCT Definium 8000 Discovery XR656 Discovery XR650 Optima XR640 Optima CT660sPro Optima CT660 Optima CT660s Optima CT660Pro Console Generation Upgrade CortexID Suite IQST assembly Quality Care Suite 2 GSI Viewer GSI Volume Viewer Discovery CT750 HD Operator Console for BrightSpeed Elite_BrightSpeed Elite Select Optima CT540 Precision 500D LightSpeed VCT LightSpeed VCT XTe Prestige VH Prestige SI Prestige II Prestige Remote R&F System Definium 5000 Low Dose CT Lung Cancer Screening Option for Qualified GE CT Systems Precision DL Photonova Spectra Select Photonova Spectra Precision 500D P500D Revolution CT Revolution CT ES Revolution Apex Revolution CT with Quantix Upgrade Revolution CT with Apex Edition MaxFOV 2 LightSpeed VCT LightSpeed VCT Select LightSpeed VCT standard LightSpeed VCT XT LightSpeed Pro32 Critical Care Suite with Enteric Tube Positioning AI Algorithm CRC Customer Remote Console Remote Console Digital Expert Access AS Auto Segmentation Critical Care Suite with Endotracheal Tube Positioning AI Algorithm Critical Care Suite 2 Discovery RT Discovery CT590 RT Optima CT580 W Optima CT580 Optima CT580 RT LightSpeed VCT Select LightSpeed VCT LightSpeed Pro32 SmartView 3D Option GE Veo Reconstruction Option Veo Collimator Collimator X-Ray Brivo XR285amx Optima XR220amx Optima XR200amx Enhanced Extream Injector Option Extream Injector Option ASiR-V Discovery IQ Discovery IQ Clarity RT Refresh Package Discovery RT SmartMAR Optima RT OPTIMA CT580 OPTIMA CT580 W OPTIMA CT580 RT Revolution RT DISCOVERY CT590 RT Discovery MI Columbia Discovery MI Discovery Max Discovery MI Gen2 Discovery Max+ Optima CT660SE Optima CT660ProJ Optima CT660FREEdom Optima CT660Pro Optima CT660sPro Optima CT660J Optima CT660 Revolution EVO 33 kW/48 kW Optima CT660s Revolution EVO Revolution EVO EL Revolution EVO ES Revolution EVO EX Optima CT680 Expert Optima CT680 Quantum Optima CT 670 Optima CT680 Professional CT660 Cj2.5 Upgrade Console Generation Upgrade SnapShot Freeze SnapShot Freeze 2 SSF2 SSF CARDIOVASCULAR PHANTOM Disocvery PET/CT 610 Clarity Discovery PET/CT 690 Discovery PET/CT 600 Optima 560 / Discovery 690 Elite Discovery PET/CT 610 Discovery PET/CT 710 Optima PET/CT 560 Optima PET/CT 560FX Optima XR240amx Deep Learning Image Reconstruction (DLIR) TrueFidelity PET Digital Gating MotionFree Critical Care Suite 2.1 Optima XR240amx Discovery CT Revolution Frontier Revolution Frontier ES Discovery CT750 HD Revolution HD Revolution Frontier Gen 3_HD Refresh Package Revolution Discovery CT Revolution CT with Apex Edition Revolution CT Revolution Apex Revolution CT ES Revolution CT ES with Apex edition Revolution Apex Plus Max Apollo + Max Elite + Omni Legend Optima CT680 Expert Revolution Maxima Revolution Ace Console Generation Upgrade Lunar iDXA series Collimator Assembly X-Ray Collimator OEC Beam Limiting Device HELIOS Collimator Prodigy/DPX Series Collimator Assembly Wolverine Collimator Volume Viewer Reporting Tool Volume Viewer 4 Preprocessing Enabler PROView Volume Viewer MR Volume Viewer 2 Volume Viewer Innova Volume Viewer PET OncoQuant Volume Viewer Apps Volume Viewer 5 Autolaunch Volume Viewer 3.1 Volume Illumination Volume Viewer Innova 3DStent Volume Viewer Innova Enhanced Head Auto Views HAV AMX Navigate AMX Navigate UPGRADE Spectral Bone Marrow SBM Revolution CT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2018-02-09
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-02-09
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2022-09-06
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-09-06
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-09
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2010-06-09
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2010-06-15
IZF	System, X-Ray, Tomographic	Radiology	Class 2	892.1740	2010-06-15
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2010-06-15
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-08-17
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2014-11-13
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	2009-04-30
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-09
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-09
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2007-11-05
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-09
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2012-09-11
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2012-01-09
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2012-01-09
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-02-06
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2023-05-15
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-03-23
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2013-08-20
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-01-04
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-03-02
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-09
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-04-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-09-09
QKB	Radiological Image Processing Software For Radiation Therapy	Radiology	Class 2	892.2050	2023-05-23
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2022-01-14
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-05-06
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-09
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-01-16
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-10-18
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2011-06-27
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-09
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-12-10
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2014-09-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-05-05
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2016-08-12
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2016-08-12
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-09-11
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-03-29
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-03-29
IXG	Phantom, Anthropomorphic, Radiographic	Radiology	Class 1	892.1950	1978-02-22
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2010-06-09
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2017-01-04
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2017-01-04
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-02-21
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2018-05-30
QBS	Radiological Computer Assisted Detection/Diagnosis Software For Fracture	Radiology	Class 2	892.2090	2023-09-29
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2018-11-02
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-11-02
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2012-10-09
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-07-30
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-08-12
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2024-08-12
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-10-28
IZW	Collimator, Automatic, Radiographic	Radiology	Class 2	892.1610	2014-12-02
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2010-06-23
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2010-06-23
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-23
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2021-06-03
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2021-06-03
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-08-16
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2023-08-16
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-04-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GE HealthCare Technologies Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3015060224	IMACTIS, SAS	SAINT MARTIN D'HERES, FR
2122726	GE MEDICAL SYSTEMS, LLC	Milwaukee, WI, US
9617766	GE BE PRIVATE LIMITED	WHITEFIELD, BANGALORE Karnataka, IN
9710090	GE ULTRASOUND KOREA, LTD.	Seongnam-Si Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K153059	Minxray, Inc.	HF1202H PowerPlus Portable X-ray Equipment	2016-02-02
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16
K190691	Pixxgen Corporation	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04
K150150	Rayence Co., Ltd.	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	2015-03-27
K140771	Philips Medical Systems Dmc GmbH	PHILIPS ELEVA WORKSPOT	2014-04-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2009	GE Medical Systems, LLC	2	Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434
Z-0003-2009	GE Medical Systems, LLC	2	Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. Intended for use in generating Tomographic images of human anatomy.
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-0008-2011	GE Healthcare, LLC	2	GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Z-0009-2011	GE Healthcare, LLC	2	GE Datex-Ohmeda Avance Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Z-0009-2014	GE Healthcare, LLC	2	GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
Z-0010-2011	GE Healthcare, LLC	2	GE Datex-Ohmeda Amingo Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Z-0010-2014	GE Healthcare, LLC	2	GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.
Z-0010-2015	GE Healthcare, LLC	2	GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations.
Z-0012-05	General Electric Med Systems LLC	2	Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.
Z-0012-2014	GE Healthcare, LLC	2	GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations. - The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0021-2014	GE Healthcare, LLC	2	GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies.
Z-0023-2014	GE Healthcare, LLC	2	GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
Z-0024-2014	GE Healthcare, LLC	2	GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2126677. Last updated year: 2026. Please use registration number 2126677 when referencing this establishment in official correspondence.