Ge Medical Systems Information Technologies, Inc. - FDA 510(k) Cleare...
31
Total
31
Cleared
0
Denied
Ge Medical Systems Information Technologies, Inc. has 31 FDA 510(k) cleared cardiovascular devices. Based in Milwaukee, US.
Latest FDA clearance: Jan 2026. Active since 2010.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Ge Medical Systems Information...
31 devices
Cleared
Jan 26, 2026
MAC 7 Resting ECG Analysis System
Cardiovascular
241d
Cleared
Jul 09, 2025
Monitor B105M
Cardiovascular
315d
Cleared
Dec 12, 2024
Mac-Lab (AltiX AI.i)
Cardiovascular
27d
Cleared
Apr 25, 2024
Portrait VSM
Cardiovascular
147d
Cleared
Mar 20, 2024
Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central...
Anesthesiology
83d
Cleared
Dec 13, 2023
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
Cardiovascular
170d
Cleared
Aug 11, 2023
Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core...
Anesthesiology
157d
Cleared
Mar 14, 2023
ONE-CUF
Cardiovascular
55d
Cleared
Dec 21, 2022
Mural Clinical Viewer
Cardiovascular
117d
Cleared
Dec 20, 2022
EK12 V2 Algorithm
Cardiovascular
173d
Cleared
Oct 18, 2022
MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
Cardiovascular
165d
Cleared
Jun 23, 2022
Mural Perinatal Surveillance
Obstetrics & Gynecology
101d