Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012359877

FEI Number

3012359877

Entity Name

GE Medical Systems Information Technologies, Inc.

City/State/Country

Wauwatosa, WI, US

Establishment Address

9900 Innovation Drive, Wauwatosa, WI 53226, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K221321

PMA Number

N/A

All Registered Proprietary Names

MAC 2000 12SL ECG Analysis Program B1X5-REC, Recorder Radial-Cuf Non-invasive Blood Pressure Cuff 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) DURA-CUF CLASSIC-CUF SENSA-CUF SOFT-CUF NIBP Hoses NIBP connectors NIBP adaptors (Dinaclick, Bayonet, Neo-Snap) ECG Trunk Cables and Leadwires Trunk Cables (Cardiac Output Cables, Invasive Blood Pressure Cables, Temperature Cables) ECG Adapter Cable NOVII INTERFACE CABLE - GE FECG MECG Cable FECG Cable CLAB ECG Trunk Cable 12-lead AHA 10ft CLAB ECG Trunk Cable 12-lead IEC 10ft NOVII INTERFACE CABLE - GE MECG Novii Cables (NOVII INTERFACE CABLE - GE FECG; NOVII INTERFACE CABLE - GE MECG; NOVII INTERFACE CABLE - GE UA) 4 Leadwire Expansion Cable, grabber, IEC, 74 cm/29 in. NOVII INTERFACE CABLE - GE UA 4 Leadwire Expansion Cable, snap, IEC, 74 cm/29 in. 4 Leadwire Expansion Cable, grabber, IEC, 130 cm/51 in. Cable assembly ECG 3 lead neo IEC long, 3.6 m Cable assembly ECG 3 lead neo AHA short, 1.8 m Cable assembly ECG 3 lead neo AHA long, 3.6 m 4 Leadwire Expansion Cable, snap, IEC, 130 cm/51 in. Cable assembly ECG 3 lead neo IEC short, 1.8 m 4 Leadwire Expansion Cable, snap, AHA, 130 cm/51 in. 4 Leadwire Expansion Cable, grabber, AHA, 74 cm/29 in. 4 Leadwire Expansion Cable, snap, AHA, 74 cm/29 in. 4 Leadwire Expansion Cable, grabber, AHA, 130 cm/51 in. B1X5-F2, Second Frame B125M Patient Monitor B105P Patient Monitor Monitor B105M Monitor B125M Monitor B155M B125P Patient Monitor Monitor B125P B105M Patient Monitor Monitor B105P B155M Patient Monitor 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 EK12 V2 MLCL Upgrade BT21 SpecialsLab v6.9.6 R3 ComboLab v6.9.6 R3 CardioLab v7 ComboLab v7 CardioLab v6.9.6 R3 Mac-Lab v7 Mac-Lab v6.9.6 R3 CARESCAPE ONE CARESCAPE ECG CARESCAPE TEMP CARESCAPE PRES CARESCAPE SPO2 CARESCAPE DOCK FO CARDIOSOFT WEB CardioSoft V6.71. Cardiac Testing System CS V6.71 Cardiac Testing System CARDIOSOFT RESTING ECG CS V6.6. Cardiac Testing System CASE CASE V6.6. Cardiac Testing System CARDIOSOFT EKG VIEWER CASE V6.71. Cardiac Testing System CARDIOSOFT CLIENT Cardiosoft V6.72 CASE V6.7 CS V6.71 CARDIOSOFT EXERCISE STRESS TEST CardioSoft V6.73 CS V6.6 Cardiac Testing System CARDIOSOFT SERVER CardioSoft V6.71 Cardiac Testing System CASE V6.6 Cardiac Testing System CASE V6.71 Cardiac Testing System CASE V6.73 eMUSE Cardiology Information System MUSE Cardiology Information System MUSE Cardiology Information System V9 MUSE MUSE v9 MUSE NX HEART-Exercise B125M Patient Monitor B1X5-F2, Second Frame B155M Patient Monitor B105P Patient Monitor Monitor B105M Monitor B125M B105M Patient Monitor VSP 4 Upgrade Software Monitor B155M Monitor B125P Monitor B105P B125P Patient Monitor Portrait Core Services CSSXB Portrait RR P-RR01 Portrait BCH01 Portrait MMP01 Portrait AAB01 Portrait SpO2 P-W01 Portrait SpO2 P-SP01 Portrait SBT01 Portrait SpO2 P-SE01 Portrait SpO2 P-SA01 Portrait RRP01 Portrait CVAXB Portrait HUBXB Portrait HSWXB Portrait CAU01 CASE V7 Cardiac Testing System CardioSoft V7 Cardiac Testing System CSCS CSCS v2 CARESCAPE Central Station CARESCAPE Central Station v2 CARESCAPE Central Station v3 CSCS v3 MAC 3500 MAC 5500 HD MAC 5500 HD ECG ANALYSIS SYSTEM CAM HD CAM 14 CareIntellect Perinatal Mural Perinatal Surveillance MAC 600 Resting ECG Analysis System MAC 600 12SL ECG Analysis Program MAC 5 A4 MAC 5 A4 Resting ECG Analysis System MAC 5 A5 MAC 5 Lite Resting ECG Analysis System MAC 5 Lite MAC 5 A5 Resting ECG Analysis System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2014-02-17
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2014-02-17
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2014-02-17
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2017-01-25
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	1995-07-11
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2013-04-16
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
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2012-11-07
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2018-06-06
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2022-04-04
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-04-04
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2022-04-04
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-04-04
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2022-04-04
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2022-04-04
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-04
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2022-04-04
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2022-04-04
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-04-04
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2022-04-04
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-04
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2022-04-04
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2022-04-04
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2022-04-04
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-04-04
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2022-04-04
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2022-04-04
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2022-04-04
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-04
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-04
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2022-04-04
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2022-04-04
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2022-04-04
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2022-04-04
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2022-04-04
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2022-04-04
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2010-06-30
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2022-12-22
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2013-07-17
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2020-03-30
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2020-03-30
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2020-03-30
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2020-03-30
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2020-03-30
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2020-03-30
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2020-03-30
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2020-03-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-03-30
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-03-30
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2020-03-30
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-03-30
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2020-03-30
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2020-03-30
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2011-08-26
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2016-01-15
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-03-11
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2025-03-11
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2026-05-14
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2026-05-14
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2026-05-14
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2026-05-14
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2026-05-14
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2026-05-14
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2026-05-14
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2026-05-14
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2026-05-14
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2026-05-14
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-05-14
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-05-14
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2026-05-14
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2026-05-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-05-14
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2026-05-14
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-05-14
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2026-05-14
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2026-05-14
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2026-05-14
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2026-05-14
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-05-14
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2026-05-14
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2026-05-14
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2026-05-14
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2026-05-14
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-05-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-03-23
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2024-03-23
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2024-03-23
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2024-03-23
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-03-23
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-12-20
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
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2011-05-11
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2011-05-11
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2011-05-11
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2022-07-13
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2011-05-19
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2010-04-16
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2022-10-31
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-10-31
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-10-31

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
K820986	Dart Medical Equipment	EKG MONITORS, VARIOUS MODELS	1982-04-29
K910450	Medtech Industries, Inc.	CARD GUARD-3000 ECG TELEPHONE ADAPTER	1991-05-07
K761318	Cambridge Instruments, Inc.	3038 OPTION B-COMPUT. TRANS. TERMINAL	1977-01-06
K972649	Reynolds Medical , Ltd.	CARDIOCALL CARDIAC EVENT RECORDER	1997-12-04
K033410	Remote Diagnostic Technologies , Ltd.	TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002	2004-03-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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 3012359877. Last updated year: 2026. Please use registration number 3012359877 when referencing this establishment in official correspondence.