Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616047

FEI Number

3003377038

Entity Name

GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V.

City/State/Country

APODACA Nuevo Leon, MX

Establishment Address

CALLE ESPANA No. 300, PARQUE INDUSTRIAL HUINALA, APODACA Nuevo Leon C.P.66645, MX

Establishment Type(s)

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

K113490

PMA Number

N/A

All Registered Proprietary Names

Optima MR450w 1.5T Discovery MR450 1.5T Discovery MR750 3T SIGNA Artist Discovery MR750w 3T SIGNA Architect Definium Pace Select ET Lunar iDXA series Collimator Assembly X-Ray Collimator OEC Beam Limiting Device HELIOS Collimator Prodigy/DPX Series Collimator Assembly Wolverine Collimator OVERHEAD TUBE SUSPENSION (OTS for Definium Tempo Pro and Definium Tempo) (Model: 5822306) OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-7) Tubestand (Model: GCTS-C1) OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-9) OVERHEAD TUBE SUSPENSION (OTS for Definium Tempo Pro and Definium Tempo) (Model: 5822306-1) OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-10) Tubestand (Model: GCTS-C11) OVERHEAD TUBE SUSPENSION (OTS for Discovery XR656 HD) (Model: 5135678-11) OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-8) Discovery XR656 HD with VolumeRad Definium Tempo Definium Tempo Pro Optima XR646 HD Upgrade Discovery XR656 HD Optima XR646 HD Discovery XR656 HD Upgrade Critical Care Suite 2.1 Discovery MR750w 3T Discovery MR750W MR 750W 3T GEM PA (Aurora only) 3T GEM HNU (Aurora only) 3T GEM PVA (Aurora only) 3T GEM Anterior Array (Aurora only) AMX Navigate AMX Navigate UPGRADE iDXA Prodigy Advance Prodigy Primo Prodigy Lunar iDXA GE Lunar DXA Bone Densitometers with enCORE version 17 Prodigy Pro Prodigy Pro Compact Prodigy Primo Compact Critical Care Suite with Endotracheal Tube Positioning AI Algorithm Critical Care Suite 2 Performix Plus LU43318ST LU8548STR Performix 40 Plus MAXIRAY 100 TH-M1 APOLLON Solarix 350 Brightspeed Performix HD 43318 45645 Performix Pulsar Performix VCT Plus Performix 40 LU45649ST LU45645STR Vamana Surgery MX100 FL MX135CT TH1.1 Maxiray MX100 FL Maxiray CT VCT MX200CT/Performix Ultra 5855555 LU45645 SB-80-200R Performix 160A LU8743STR Ergo MONOBLOCK Performix Pro VCT 100 LU45649 Maxiray MX100 RAD LU45649STR LU45645ST LU40782 Brivo OEC 2.2A X-ray Generator MX100 RAD LU8743ST Vamana RAD LU8548ST 40782 Performix HD Plus Artemis MX165 NP Quantix 160 Maxiray CT Ultra Performix HDw Prodigy Pro Prodigy Prodigy Advance Prodigy Primo Definium Tempo Select iDXA Lunar iDXA Lunar Astra Jedi TTH Jedi80RF1T Jedi80R1T Jedi 80 RD 1T Jedi42CT Jedi 50 Plus R1T ZEUS Zyx Jedi 80 RF 1T Jedi50R1T JEDI 80 RF1T Jedi 50 R 1T Jedi NP+V1.5 TTH MAESTRO TTH HAWKEYE DMR JEDI 60 DC Jedi 60 DC Djinn Mammo Jedi80RF2T Prisme Jedi 42 CT JEDI SC FAST kV DJINN BEETLE VMX MPPU JEDI HP JEDI 100 VASC 1T CT MINI Jedi60CT X-Ray Generator ZJ/QJ Prodigy/DPX Series High Voltage Power Supply Jedi 60 DC LITE SYJ MPG50 JEDI 60 DC LITE Jedi 60DC Lite MPG100 VAMP Jedi 80 RF 2T JEDI VCT Jedi 80 R 1T TTH 8800 ZEUS, ZJ/QJ Jedi 100 VASC 1 BONZAI Djinn Beetle Jedi 60 CT Jedi 60DC GAIA INTERVENTIONAL GENERATOR Djinn Tonix Discovery MR450 Optima MR450w 1.5T Discovery MR750 3T SIGNA Architect Discovery MR450 1.5T SIGNA Artist Discovery MR750w 3T Prodigy GE Lunar DXA Bone Densitometers with enCORE version 16 Lunar iDXA iDXA GEHC DXA Bone Densitometers with enCORE version 18 Prodigy Primo Prodigy Pro Compact Prodigy Advance Lunar iDXA Prodigy Pro Prodigy Primo Compact Prodigy Optima MR450w 1.5T GEM PA 1.5T GEM Anterior Array 1.5T GEM HNU 1.5T GEM PVA GEM Option for 1.5T MRI Systems Optima MR450w GEM XP Gradient Optima MR450w GEM Optima MR450w

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2017-04-13
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2024-10-28
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2024-10-28
IZW	Collimator, Automatic, Radiographic	Radiology	Class 2	892.1610	2014-12-02
IYB	Tube Mount, X-Ray, Diagnostic	Radiology	Class 1	892.1770	1978-03-16
IZF	System, X-Ray, Tomographic	Radiology	Class 2	892.1740	2019-09-06
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2019-09-06
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2019-09-06
QBS	Radiological Computer Assisted Detection/Diagnosis Software For Fracture	Radiology	Class 2	892.2090	2023-09-29
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2011-11-03
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2011-11-03
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2011-11-03
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
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2017-01-12
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2022-01-14
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	1999-10-06
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2007-10-16
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2025-08-29
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2025-08-29
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2007-10-16
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2026-06-18
IZO	Generator, High-Voltage, X-Ray, Diagnostic	Radiology	Class 1	892.1700	2004-09-24
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2016-07-08
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2014-09-08
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2019-10-08
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2010-07-15
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2011-03-23
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2012-01-16

Official Correspondent

No official correspondent registered.

US Agent Details

Tracey Holevas Business: GE HealthCare Technologies, Inc Email: tracey.holevas@gehealthcare.com Phone: (262) 3092157

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
K033504	General Electric Co.	GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM	2003-11-25
K013636	GE Medical Systems	SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY	2002-01-24
K250443	Siemens Healthcare GmbH	MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile	2025-06-16
K151015	Hitachi Medical Systems America, Inc.	ECHELON Oval V 5.0 MRI System	2015-07-29
K910715	Philips Medical Systems (Cleveland), Inc.	VISTA HPQ SYSTEM	1991-06-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2007	Hitachi Medical Systems America Inc	2	MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Z-0033-2014	Philips Medical Systems (Cleveland) Inc	2	Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Z-0389-2024	Philips North America Llc	2	Achieva 1.5T
Z-0390-2024	Philips North America Llc	2	Achieva 1.5T Conversion
Z-0391-2024	Philips North America Llc	2	Achieva 1.5T Initial System

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616047. Last updated year: 2026. Please use registration number 9616047 when referencing this establishment in official correspondence.