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Ge Medical Systems Information Technologies: FDA-registered device maker in El Paso, TX, United States, 18 510(k) clearances

Name: Ge Medical Systems Information Technologies FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ge Medical Systems Information Technologies is registered with the FDA (registration 1651104) in El Paso, TX, United States. It lists 39 device types. The FDA files 18 510(k) clearances under its listings, the newest dated July 24, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 1651104
FEI number: 3002737156
Address: 465 Pan American DR Ste 11, El Paso, TX, United States, 79907
Owner or operator: GE HealthCare Technologies Inc. (9912004)
Roles: Manufacturer, Repackager or relabeler
First device listed: June 30, 2010
Registered through: 2027
Brand names listed: APEXPRO CH NONIN XPOD OXIMETER, APEXPRO QUAD RECEIVER MODULE, APEXPRO RECEIVER SUBSYSTEM, ApexPro 400 MHz Receiver, ApexPro 600 MHz Receiver, ApexPro CH Transmitter, ApexPro FH Transceiver, ApexPro Telemetry System and more

Devices it lists

Device	Product code	Class	Role	Source
Alarm, Blood-Pressure	DSJ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	NHO	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	CBQ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	CBS	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	NHQ	2	Repackager or relabeler	accessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	CBR	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-Phase	CCL	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	NHP	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Burst Suppression Detection Software For Electroencephalograph	ORT	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cerebral Oximeter	QEM	2	Repackager or relabeler	accessdata.fda.gov
Computer, Blood-Pressure	DSK	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-Function	DXG	2	Repackager or relabeler	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Computer, Oxygen-Uptake	BZL	2	Repackager or relabeler	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Detector And Alarm, Arrhythmia	DSI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Display, Cathode-Ray Tube, Medical	DXJ	2	Repackager or relabeler	accessdata.fda.gov
Electrocardiograph	DPS	2	Repackager or relabeler	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Index-Generating Electroencephalograph Software	OLW	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	CAP	2	Repackager or relabeler	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Monitor, St Segment With Alarm	MLD	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Oximeter	DQA	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Oximeter, Ear	DPZ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Oximeter, Tissue Saturation	MUD	2	Repackager or relabeler	accessdata.fda.gov
Probe, Thermodilution	KRB	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Reduced- Montage Standard Electroencephalograph	OMC	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Spirometer, Monitoring (W/Wo Alarm)	BZK	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Auditory, Evoked Response	GWJ	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Nerve, Peripheral, Electric	KOI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Network And Communication, Physiological Monitors	MSX	2	Manufacturer	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	2	Manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 24, 2026	K253277	Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P	MHX	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.	accessdata.fda.gov
December 12, 2024	K243540	Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)	DQK	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.	accessdata.fda.gov
April 25, 2024	K233810	Portrait VSM	MWI	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.	accessdata.fda.gov
March 20, 2024	K234130	Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O	MWI	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.	accessdata.fda.gov
December 13, 2023	K231870	CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System	DQK	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.	accessdata.fda.gov
August 11, 2023	K230626	Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services (Portrait CSS01), Portrait Clinical Alarming Unit (Portrait CAU01); Portrait Mobile Patient Monitor (Portrait HUB01), Portrait Sensor Battery (Portrait SBT01), Portrait Bedside Charger (Portrait BCH01); Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait SpO2 Attachment Accessory Band (Portrait AAB01), Portrait	MWI	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.	accessdata.fda.gov
April 6, 2023	K223531	CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)	MHX	Substantially Equivalent	GE Healthcare Finland Oy	accessdata.fda.gov
December 20, 2022	K221904	EK12 V2 Algorithm	MHX	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.	accessdata.fda.gov
April 13, 2022	K213363	CARESCAPE B450, E-musb	MHX	Substantially Equivalent	GE Healthcare Finland Oy	accessdata.fda.gov
April 13, 2022	K213181	CARESCAPE B650, E-musb	MHX	Substantially Equivalent	GE Healthcare Finland Oy	accessdata.fda.gov
April 12, 2022	K213234	CARESCAPE 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 MKS201	MHX	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.	accessdata.fda.gov
February 17, 2022	K213972	Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX	DQK	Substantially Equivalent	Ge Healthcare Information Technologies, Inc.	accessdata.fda.gov
September 15, 2016	K162012	CARESCAPE Central Station V2	DXJ	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
January 12, 2016	K152993	MUSE Cardiology Information System	DQK	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.	accessdata.fda.gov
May 1, 2013	K130626	MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS	DQK	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.	accessdata.fda.gov
February 16, 2011	K103678	CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM	DQK	Substantially Equivalent	Ge Medical Systems Information Technologies GmbH	accessdata.fda.gov
June 20, 2008	K080251	APEXPRO TELEMETRY SYSTEMS	MHX	Substantially Equivalent	Ge Medical Systems Information Technologies	accessdata.fda.gov
May 11, 2007	K071073	SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE	MHX	Substantially Equivalent	Ge Medical Systems Information Technologies	accessdata.fda.gov

Compare with other makers

Updated July 24, 2026. 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.