Ge Medical Systems Information Technologies, Inc. - FDA 510(k) Cleare...
31
Total
31
Cleared
0
Denied
FDA 510(k) cleared devices by Ge Medical Systems Information... Cardiovascular ✕
28 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
Dec 13, 2023
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
Cardiovascular
170d
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
Apr 12, 2022
CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101,...
Cardiovascular
194d
Cleared
Apr 01, 2022
Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
Cardiovascular
151d
Cleared
Apr 30, 2021
MAC 7 - Resting ECG Analysis System
Cardiovascular
123d