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Data / Medical devices / United States / Repair Operations Center

Repair Operations Center: FDA-registered device maker in Oak Creek, WI, United States, 10 510(k) clearances

Repair Operations Center is registered with the FDA (registration 3013679558) in Oak Creek, WI, United States. It lists 42 device types. The FDA files 10 510(k) clearances under its listings, the newest dated April 13, 2022. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Repair Operations Center
FDA registration number
3013679558
Address
120 Opus Drive, Oak Creek, WI, United States, 53154
Owner or operator
GE HealthCare Technologies Inc. (9912004)
Roles
Remanufacturer
First device listed
July 7, 2011
Registered through
2027
Brand names listed
AMX Navigate, AMX Navigate UPGRADE, CARESCAPE B450, CARESCAPE B650, CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE ONE, CARESCAPE PRES and more

Devices it lists

DeviceProduct codeClassRoleSource
Alarm, Blood-PressureDSJ2Remanufactureraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Remanufactureraccessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)NHO2Remanufactureraccessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)CBQ2Remanufactureraccessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)CBS2Remanufactureraccessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)NHQ2Remanufactureraccessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)CBR2Remanufactureraccessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-PhaseCCL2Remanufactureraccessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)NHP2Remanufactureraccessdata.fda.gov
Burst Suppression Detection Software For ElectroencephalographORT2Remanufactureraccessdata.fda.gov
Cerebral OximeterQEM2Remanufactureraccessdata.fda.gov
Computer, Blood-PressureDSK2Remanufactureraccessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-FunctionDXG2Remanufactureraccessdata.fda.gov
Computer, Diagnostic, ProgrammableDQK2Remanufactureraccessdata.fda.gov
Computer, Oxygen-UptakeBZL2Remanufactureraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Remanufactureraccessdata.fda.gov
Detector And Alarm, ArrhythmiaDSI2Remanufactureraccessdata.fda.gov
ElectrocardiographDPS2Remanufactureraccessdata.fda.gov
Full-Montage Standard ElectroencephalographGWQ2Remanufactureraccessdata.fda.gov
Index-Generating Electroencephalograph SoftwareOLW2Remanufactureraccessdata.fda.gov
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)CAP2Remanufactureraccessdata.fda.gov
Monitor, Breathing FrequencyBZQ2Remanufactureraccessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT2Remanufactureraccessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX2Remanufactureraccessdata.fda.gov
Monitor, St Segment With AlarmMLD2Remanufactureraccessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph SoftwareOLT2Remanufactureraccessdata.fda.gov
OximeterDQA2Remanufactureraccessdata.fda.gov
Oximeter, EarDPZ2Remanufactureraccessdata.fda.gov
Oximeter, Tissue SaturationMUD2Remanufactureraccessdata.fda.gov
Probe, ThermodilutionKRB2Remanufactureraccessdata.fda.gov
Reduced- Montage Standard ElectroencephalographOMC2Remanufactureraccessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)MQB2Remanufactureraccessdata.fda.gov
Spirometer, Monitoring (W/Wo Alarm)BZK2Remanufactureraccessdata.fda.gov
Stimulator, Auditory, Evoked ResponseGWJ2Remanufactureraccessdata.fda.gov
Stimulator, Nerve, Peripheral, ElectricKOI2Remanufactureraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Remanufactureraccessdata.fda.gov
System, Nuclear Magnetic Resonance ImagingLNH2Remanufactureraccessdata.fda.gov
System, Tomography, Computed, EmissionKPS2Remanufactureraccessdata.fda.gov
System, X-Ray, MobileIZL2Remanufactureraccessdata.fda.gov
System, X-Ray, StationaryKPR2Remanufactureraccessdata.fda.gov
System, X-Ray, TomographicIZF2Remanufactureraccessdata.fda.gov
System, X-Ray, Tomography, ComputedJAK2Remanufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 13, 2022K213363CARESCAPE B450, E-musbMHXSubstantially EquivalentGE Healthcare Finland Oyaccessdata.fda.gov
April 13, 2022K213181CARESCAPE B650, E-musbMHXSubstantially EquivalentGE Healthcare Finland Oyaccessdata.fda.gov
April 12, 2022K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201MHXSubstantially EquivalentGe Medical Systems Information Technologies, Inc.accessdata.fda.gov
December 17, 2021K213715Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex editionJAKSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
April 28, 2021K210982AMX NavigateIZLSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
July 24, 2019K191699Discovery XR656 HD with VolumeRadKPRSubstantially EquivalentGe Hualun Medical Systems Co. , Ltd.accessdata.fda.gov
March 17, 2017K163331Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA ArtistLNHSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
November 15, 2016K162990Optima XR240amxIZLSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
January 17, 2014K132410DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 WJAKSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
June 3, 2011K111445DISCOVERY NM 630KPSSubstantially EquivalentGE Healthcareaccessdata.fda.gov

Compare with other makers

Updated April 13, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.