Repair Operations Center

FDA Device Registration & Listing · Oak Creek, WI, US · Registration 3013679558

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
3013679558
FEI Number
3013679558
Entity Name
Repair Operations Center
City/State/Country
Oak Creek, WI, US
Establishment Address
120 Opus Drive, Oak Creek, WI 53154, US
Establishment Type(s)
Remanufacture 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
Y
Expiration Date (Year)
2026
510(k) Number
K111445
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 Optima XR240amx E-musb CARESCAPE B650 CARESCAPE RAD E-musb CARESCAPE B450 CARESCAPE RAD 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

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
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
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Anesthesiology Class 2 868.2600 2022-04-20
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2022-04-20
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2022-04-20
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2022-04-20
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2022-04-20
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-04-20
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2022-04-20
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-04-20
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2022-04-20
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-04-20
KOI Stimulator, Nerve, Peripheral, Electric Anesthesiology Class 2 868.2775 2022-04-20
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2022-04-20
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-04-20
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2022-04-20
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2022-04-20
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2022-04-20
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-04-20
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2022-04-20
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2022-04-20
QEM Cerebral Oximeter Cardiovascular Class 2 870.2700 2022-04-20
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2022-04-20
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2022-04-20
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2022-04-20
BZL Computer, Oxygen-Uptake Anesthesiology Class 2 868.1730 2022-04-20
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2022-04-20
ORT Burst Suppression Detection Software For Electroencephalograph Neurology Class 2 882.1400 2022-04-20
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2022-04-20
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-04-20
KRB Probe, Thermodilution Cardiovascular Class 2 870.1915 2022-04-20
DQA Oximeter Cardiovascular Class 2 870.2700 2022-04-20
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2022-04-20
OLW Index-Generating Electroencephalograph Software Neurology Class 2 882.1400 2022-04-20
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2022-04-20
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2022-04-20
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2022-04-20
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2022-04-20
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2022-04-20
QEM Cerebral Oximeter Cardiovascular Class 2 870.2700 2022-04-20
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-04-20
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2022-04-20
KRB Probe, Thermodilution Cardiovascular Class 2 870.1915 2022-04-20
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2022-04-20
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Anesthesiology Class 2 868.2600 2022-04-20
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2022-04-20
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2022-04-20
KOI Stimulator, Nerve, Peripheral, Electric Anesthesiology Class 2 868.2775 2022-04-20
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2022-04-20
OLW Index-Generating Electroencephalograph Software Neurology Class 2 882.1400 2022-04-20
ORT Burst Suppression Detection Software For Electroencephalograph Neurology Class 2 882.1400 2022-04-20
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-04-20
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2022-04-20
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2022-04-20
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2022-04-20
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2022-04-20
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2022-04-20
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-04-20
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2022-04-20
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2022-04-20
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2022-04-20
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2022-04-20
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2022-04-20
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2022-04-20
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2022-04-20
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2022-04-20
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2022-04-20
DQA Oximeter Cardiovascular Class 2 870.2700 2022-04-20
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-04-20
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-04-20
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2022-04-20
BZL Computer, Oxygen-Uptake Anesthesiology Class 2 868.1730 2022-04-20
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 2021-12-22
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2011-07-07

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
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 3013679558. Last updated year: 2026. Please use registration number 3013679558 when referencing this establishment in official correspondence.
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