Search FDA 510(k) Devices

5,516 clearances indexed · Search by device name, K-number, manufacturer or product code

170 results for "Ge Medical Systems Information Technologies"
1–24 of 170
Cleared Jan 26, 2026
MAC 7 Resting ECG Analysis System
K251670 · DPS
Ge Medical Systems Information...
Cardiovascular · 241d
Cleared Jul 09, 2025
Monitor B105M
K242562 · MHX
Ge Medical Systems Information...
Cardiovascular · 315d
Cleared Dec 12, 2024
Mac-Lab (AltiX AI.i)
K243540 · DQK
Ge Medical Systems Information...
Cardiovascular · 27d
Cleared Apr 25, 2024
Portrait VSM
K233810 · MWI
Ge Medical Systems Information...
Cardiovascular · 147d
Cleared Mar 20, 2024
Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central...
K234130 · MWI
Ge Medical Systems Information...
Anesthesiology · 83d
Cleared Dec 13, 2023
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
K231870 · DQK
Ge Medical Systems Information...
Cardiovascular · 170d
Cleared Aug 11, 2023
Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core...
K230626 · MWI
Ge Medical Systems Information...
Anesthesiology · 157d
Cleared Mar 14, 2023
ONE-CUF
K230145 · DXQ
Ge Medical Systems Information...
Cardiovascular · 55d
Cleared Dec 21, 2022
Mural Clinical Viewer
K222586 · MHX
Ge Medical Systems Information...
Cardiovascular · 117d
Cleared Dec 20, 2022
EK12 V2 Algorithm
K221904 · MHX
Ge Medical Systems Information...
Cardiovascular · 173d
Cleared Oct 18, 2022
MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
K221321 · DPS
Ge Medical Systems Information...
Cardiovascular · 165d
Cleared Jun 23, 2022
Mural Perinatal Surveillance
K220732 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 101d
Cleared Apr 12, 2022
CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101,...
K213234 · MHX
Ge Medical Systems Information...
Cardiovascular · 194d
Cleared Apr 01, 2022
Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
K213490 · MHX
Ge Medical Systems Information...
Cardiovascular · 151d
Cleared Apr 30, 2021
MAC 7 - Resting ECG Analysis System
K203786 · DPS
Ge Medical Systems Information...
Cardiovascular · 123d
Cleared Dec 08, 2020
Graffiti
K202189 · DQK
Ge Medical Systems Information...
Cardiovascular · 126d
Cleared Nov 04, 2020
Monitor B125, Monitor B105
K201941 · MHX
Ge Medical Systems Information...
Cardiovascular · 114d
Cleared Sep 18, 2018
MAC VU360 Resting ECG Analysis System
K173830 · DPS
Ge Medical Systems Information...
Cardiovascular · 274d
Cleared Jun 06, 2017
EK12 Algorithm
K170155 · MHX
Ge Medical Systems Information...
Cardiovascular · 139d
Cleared Jan 12, 2016
MUSE Cardiology Information System
K152993 · DQK
Ge Medical Systems Information...
Cardiovascular · 91d
Cleared Feb 05, 2015
12SL ECG ANALYSIS PROGRAM
K141963 · MHX
Ge Medical Systems Information...
Cardiovascular · 202d
Cleared Apr 30, 2014
CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)
K133882 · DXJ
Ge Medical Systems Information...
Cardiovascular · 131d
Cleared Dec 04, 2013
MARS HOLTER ANALYSIS WORKSTATION
K132437 · DQK
Ge Medical Systems Information...
Cardiovascular · 121d
Cleared May 01, 2013
MAC-LAB HEMODYNAMIC RECORDING SYSTEM
K130626 · DQK
Ge Medical Systems Information...
Cardiovascular · 54d