BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

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

    Reg #: 9616047 · FEI: 3003377038 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    198
    Establishment Types
    1
    Classifications
    18

    Registration Details

    Registration Name
    GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V.
    Registration Number
    9616047
    FEI Number
    3003377038
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    CALLE ESPANA No. 300, PARQUE INDUSTRIAL HUINALA
    City
    APODACA Nuevo Leon
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K163331

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    US Agent

    Business Name
    GE HealthCare Technologies, Inc
    Contact Name
    Tracey Holevas
    Address
    3000 N. Grandview BLVD
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US
    Email
    [email protected]
    Phone
    262 3092157

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Imaging LNH
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Stationary KPR
    Collimator, Automatic, Radiographic IZW
    Tube Mount, X-Ray, Diagnostic IYB
    System, X-Ray, Tomographic IZF
    Radiological Computer Assisted Detection/Diagnosis Software For Fracture QBS
    System, Nuclear Magnetic Resonance Spectroscopic LNI
    Coil, Magnetic Resonance, Specialty MOS
    System, X-Ray, Mobile IZL
    Densitometer, Bone KGI
    Automated Radiological Image Processing Software QIH
    Assembly, Tube Housing, X-Ray, Diagnostic ITY
    Generator, High-Voltage, X-Ray, Diagnostic IZO
    Table, Radiologic KXJ
    Table, Radiographic, Non-Tilting, Powered IZZ
    Radiological Computer-Assisted Prioritization Software For Lesions QFM
    Instrument, Quality-Assurance, Radiologic LHO

    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 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 Definium Tempo Select 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 GE Lunar DXA Bone Densitometers with enCORE version 16 GEHC DXA Bone Densitometers with enCORE version 18 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 3T Detachable Table 3T eXpress Table 1.5T eXpress Table 1.5T Detachable Table NG2000 ELITE HEAVY TABLE GT1700V(GT1700V N9 ED3, GT1700V) VT1700V(GT1700V N9 ED3) GT1700V (GT1700V N9 ED3, GT1700V) VT1700 (GT1700 N9 ED3) VT2000X(GT2000x) Lite (LITE TABLE N9 ED3, Lite Table) NG 2000 Table NM/CT Patient Table VT2000 (GT2000 N9 ED3) Kunlun Table NG2000V table G3 RAD Elevation Table Standard table NG1700 Patient Table Table (Model: GCTBL-C4) Table (Model: GCTBL-C33) NG LITE 1700 (NG1700 ELITE STANDARD TABLE) NG2000SV Table NG LITE 2000 (NG2000 ELITE HEAVY TABLE) NG2000SV TABLE NG1700 ELITE STANDARD TABLE Radiographic Table (Model: VFTBL-1) NG1700SV Table Table (Model: GCTBL-C3333) NG1700SV TABLE Critical Care Suite IQST assembly Quality Care Suite 2 1.5T Split Head Coil Optima MR 450w GEM 3T SPLIT HEAD COIL Optima MR 450w Critical Care Suite with Enteric Tube Positioning AI Algorithm

    Establishment Types

    Manufacture Medical Device