Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1651104

FEI Number

3002737156

Entity Name

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES

City/State/Country

EL PASO, TX, US

Establishment Address

465 PAN AMERICAN DR STE 11, EL PASO, TX 79907, US

Establishment Type(s)

Repack or Relabel 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

K233810

PMA Number

N/A

All Registered Proprietary Names

CARESCAPE Canvas Smart Display F2 Frame (F2-01) CARESCAPE Canvas D19 CARESCAPE Canvas 1000 Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Central Viewer Application (Portrait CVA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SE01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait SpO2 Attachment Accessory Band (Portrait AAB01) Portrait Sensor Battery (Portrait SBT01) Portrait Core Services (Portrait CSS01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01) Portrait Bedside Charger (Portrait BCH01) Portrait Mobile Patient Monitor (Portrait HUB01) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Pouch (Portrait MMP01) Portrait RR Electrode Patch (Portrait RRP01) Portrait Wearable Respiration Rate Sensor (Portrait RR P-RR01) CSCS CSCS v2 CARESCAPE Central Station CARESCAPE Central Station v2 CARESCAPE Central Station v3 CSCS v3 Solar 8000i Transport Pro with Patient Data Mo Patient Data Module Defib Sync Cables ComboLab AltiX AI.i MLCL Client Software AltiX AI.i CardioLab AltiX AI.i Mac-Lab AltiX AI.i APEXPRO RECEIVER SUBSYSTEM CARESCAPE TELEMETRY SYSTEM APEXPRO CH NONIN XPOD OXIMETER APEXPRO QUAD RECEIVER MODULE ApexPro Telemetry System CARESCAPE Telemetry Server CARESCAPE T4 Transmitter ApexPro CH Transmitter CARESCAPE Telemetry T4 Transmitter CARESCAPE T14 Transmitter ApexPro FH Transceiver ApexPro 400 MHz Receiver ApexPro 600 MHz Receiver CARESCAPE Telemetry Server V4 CARESCAPE TELEMETRY SERVER V4 UPGRADE eMUSE Cardiology Information System MUSE Cardiology Information System MUSE Cardiology Information System V9 MUSE MUSE v9 MUSE NX E-musb CARESCAPE B450 CARESCAPE RAD CASE V7 Cardiac Testing System CardioSoft V7 Cardiac Testing System Portrait VSM Vital Signs Monitor Portrait VSM Portrait VSM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2023-04-14
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-04-14
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2023-04-14
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-04-14
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2023-04-14
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2023-04-14
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2023-04-14
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2023-04-14
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2023-04-14
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2023-04-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-04-14
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2023-04-14
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2023-04-14
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-04-14
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2023-04-14
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2023-04-14
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2023-04-14
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2023-04-14
QEM	Cerebral Oximeter	Cardiovascular	Class 2	870.2700	2023-04-14
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2023-04-14
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2023-04-14
BZL	Computer, Oxygen-Uptake	Anesthesiology	Class 2	868.1730	2023-04-14
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-04-14
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2023-04-14
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2023-04-14
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-04-14
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2023-04-14
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2023-04-14
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2023-04-14
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2023-04-14
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2023-04-14
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2023-04-14
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2023-04-14
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-04-14
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-04-14
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2023-08-16
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-08-16
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2023-08-16
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2023-08-16
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2023-08-16
DXJ	Display, Cathode-Ray Tube, Medical	Cardiovascular	Class 2	870.2450	2016-09-19
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2016-09-19
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2016-09-19
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2010-07-13
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-01-16
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2010-06-30
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2016-01-15
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
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-12-20
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-04-26
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-04-26
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2024-04-26
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-04-26
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2024-04-26
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-04-26

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

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K852587	Tracor Northern, Inc.	CDSA(COLOR DENSITY, SPECTRAL ARRRAY)	1985-08-16
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16

Related Recall Records

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Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1651104. Last updated year: 2026. Please use registration number 1651104 when referencing this establishment in official correspondence.