BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Repair Operations Center

    Reg #: 3013679558 · FEI: 3013679558 · Expires 2026
    View on FDA
    Products
    42
    Proprietary Names
    40
    Establishment Types
    1
    Classifications
    42

    Registration Details

    Registration Name
    Repair Operations Center
    Registration Number
    3013679558
    FEI Number
    3013679558
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    120 Opus Drive
    City
    Oak Creek
    State
    WI
    ZIP
    53154
    Country
    US

    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

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Imaging LNH
    System, X-Ray, Mobile IZL
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Electrocardiograph DPS
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Monitor, St Segment With Alarm MLD
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Stimulator, Nerve, Peripheral, Electric KOI
    Monitor, Breathing Frequency BZQ
    Continuous Measurement Thermometer FLL
    Detector And Alarm, Arrhythmia DSI
    Computer, Diagnostic, Programmable DQK
    Oximeter, Ear DPZ
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Oximeter, Tissue Saturation MUD
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Cerebral Oximeter QEM
    Stimulator, Auditory, Evoked Response GWJ
    Computer, Blood-Pressure DSK
    Full-Montage Standard Electroencephalograph GWQ
    Computer, Oxygen-Uptake BZL
    Alarm, Blood-Pressure DSJ
    Burst Suppression Detection Software For Electroencephalograph ORT
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Probe, Thermodilution KRB
    Oximeter DQA
    Reduced- Montage Standard Electroencephalograph OMC
    Index-Generating Electroencephalograph Software OLW
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Spirometer, Monitoring (W/Wo Alarm) BZK
    System, X-Ray, Tomography, Computed JAK
    System, Tomography, Computed, Emission KPS
    System, X-Ray, Tomographic IZF
    System, X-Ray, Stationary KPR

    Proprietary Names

    Optima MR450w 1.5T Discovery MR450 1.5T Discovery MR750 3T SIGNA Artist Discovery MR750w 3T SIGNA Architect Optima XR240amx E-musb CARESCAPE B650 CARESCAPE RAD CARESCAPE B450 RT Refresh Package Discovery RT SmartMAR Optima RT OPTIMA CT580 OPTIMA CT580 W OPTIMA CT580 RT Revolution RT DISCOVERY CT590 RT Revolution Apex Select Revolution CT with Apex edition Revolution Apex Select with Elite Edition Revolution Apex Select with Plus Edition Revolution CT ES Revolution CT Power Revolution Apex Elite Revolution Apex Plus Revolution CT ES with Apex edition NM 830 Discovery NM 630 Discovery XR656 HD with VolumeRad Definium Tempo Definium Tempo Pro Optima XR646 HD Upgrade Discovery XR656 HD Optima XR646 HD Discovery XR656 HD Upgrade AMX Navigate AMX Navigate UPGRADE

    Establishment Types

    Remanufacture Medical Device