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Ge Medical Systems Information Technologies, Inc. FDA Approvals
0 new drug approvals and 16 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P510(k)Jul 24, 2026Cardiovascular |
| MAC 7 Resting ECG Analysis System510(k)Jan 26, 2026Cardiovascular |
| Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P510(k)Jul 9, 2025Cardiovascular |
| Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)510(k)Dec 12, 2024Cardiovascular |
| Portrait VSM510(k)Apr 25, 2024Cardiovascular |
| 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 O510(k)Mar 20, 2024Cardiovascular |
| CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System510(k)Dec 13, 2023Cardiovascular |
| 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), Portrait510(k)Aug 11, 2023Cardiovascular |
| ONE-CUF510(k)Mar 14, 2023Cardiovascular |
| Mural Clinical Viewer510(k)Dec 21, 2022Cardiovascular |
| EK12 V2 Algorithm510(k)Dec 20, 2022Cardiovascular |
| MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System510(k)Oct 18, 2022Cardiovascular |
| Mural Perinatal Surveillance510(k)Jun 23, 2022Obstetrics/Gynecology |
| 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 MKS201510(k)Apr 12, 2022Cardiovascular |
| Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P510(k)Apr 1, 2022Cardiovascular |
| MAC 7 - Resting ECG Analysis System510(k)Apr 30, 2021Cardiovascular |