Medical Device Manufacturer · US , Milwaukee , WI

Ge Medical Systems Information Technologies, Inc.

31 submissions · 31 cleared · Since 2010
31
Total
31
Cleared
0
Denied

Ge Medical Systems Information Technologies, Inc. — FDA 510(k) Submissions

Ge Medical Systems Information Technologies, Inc. has submitted 31 FDA 510(k) premarket notifications since 2010, of which 31 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms), Computer, Diagnostic, Programmable, Electrocardiograph, Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms), Blood Pressure Cuff . Use the specialty filter in the sidebar to narrow results.

31 devices
1–25 of 31
MAC 7 Resting ECG Analysis System
K251670 · DPS Electrocardiograph · Cardiovascular
Jan 2026 241d
Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
K242562 · MHX Monitor, Physiological,... · Cardiovascular
Jul 2025 315d
Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)
K243540 · DQK Computer, Diagnostic,... · Cardiovascular
Dec 2024 27d
Portrait VSM
K233810 · MWI Monitor, Physiological,... · Cardiovascular
Apr 2024 147d
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
K234130 · MWI Monitor, Physiological,... · Anesthesiology
Mar 2024 83d
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
K231870 · DQK Computer, Diagnostic,... · Cardiovascular
Dec 2023 170d
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?
K230626 · MWI Monitor, Physiological,... · Anesthesiology
Aug 2023 157d
ONE-CUF
K230145 · DXQ Blood Pressure Cuff · Cardiovascular
Mar 2023 55d
Mural Clinical Viewer
K222586 · MHX Monitor, Physiological,... · Cardiovascular
Dec 2022 117d
EK12 V2 Algorithm
K221904 · MHX Monitor, Physiological,... · Cardiovascular
Dec 2022 173d
MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
K221321 · DPS Electrocardiograph · Cardiovascular
Oct 2022 165d
Mural Perinatal Surveillance
K220732 · HGM System, Monitoring,... · Obstetrics & Gynecology
Jun 2022 101d
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
K213234 · MHX Monitor, Physiological,... · Cardiovascular
Apr 2022 194d
Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
K213490 · MHX Monitor, Physiological,... · Cardiovascular
Apr 2022 151d
MAC 7 - Resting ECG Analysis System
K203786 · DPS Electrocardiograph · Cardiovascular
Apr 2021 123d
Graffiti
K202189 · DQK Computer, Diagnostic,... · Cardiovascular
Dec 2020 126d
Monitor B125, Monitor B105
K201941 · MHX Monitor, Physiological,... · Cardiovascular
Nov 2020 114d
MAC VU360 Resting ECG Analysis System
K173830 · DPS Electrocardiograph · Cardiovascular
Sep 2018 274d
EK12 Algorithm
K170155 · MHX Monitor, Physiological,... · Cardiovascular
Jun 2017 139d
MUSE Cardiology Information System
K152993 · DQK Computer, Diagnostic,... · Cardiovascular
Jan 2016 91d
12SL ECG ANALYSIS PROGRAM
K141963 · MHX Monitor, Physiological,... · Cardiovascular
Feb 2015 202d
CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)
K133882 · DXJ Display, Cathode-ray... · Cardiovascular
Apr 2014 131d
MARS HOLTER ANALYSIS WORKSTATION
K132437 · DQK Computer, Diagnostic,... · Cardiovascular
Dec 2013 121d
MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS
K130626 · DQK Computer, Diagnostic,... · Cardiovascular
May 2013 54d
RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF
K123996 · DXQ Blood Pressure Cuff · Cardiovascular
Apr 2013 104d
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