Ge Medical Systems Information Technologies, Inc.
FDA 510(k) & PMA Approved Devices — 21 products
Total Devices21
Categories6
Latest FDA decision2026-07-24
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | MHX | 2026-07-24 | View |
| 510(k) | K251670 | MAC 7 Resting ECG Analysis System | DPS | 2026-01-26 | View |
| 510(k) | K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | MHX | 2025-07-09 | View |
| 510(k) | K243540 | Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) | DQK | 2024-12-12 | View |
| 510(k) | K233810 | Portrait VSM | MWI | 2024-04-25 | View |
| 510(k) | K234130 | 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 | MWI | 2024-03-20 | View |
| 510(k) | K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System | DQK | 2023-12-13 | View |
| 510(k) | K230626 | 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™ | MWI | 2023-08-11 | View |
| 510(k) | K230145 | ONE-CUF | DXQ | 2023-03-14 | View |
| 510(k) | K222586 | Mural Clinical Viewer | MHX | 2022-12-21 | View |
| 510(k) | K221904 | EK12 V2 Algorithm | MHX | 2022-12-20 | View |
| 510(k) | K221321 | MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System | DPS | 2022-10-18 | View |
| 510(k) | K220732 | Mural Perinatal Surveillance | HGM | 2022-06-23 | View |
| 510(k) | K213234 | 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 | MHX | 2022-04-12 | View |
| 510(k) | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | MHX | 2022-04-01 | View |
| 510(k) | K203786 | MAC 7 - Resting ECG Analysis System | DPS | 2021-04-30 | View |
| 510(k) | K202189 | Graffiti | DQK | 2020-12-08 | View |
| 510(k) | K201941 | Monitor B125, Monitor B105 | MHX | 2020-11-04 | View |
| 510(k) | K173830 | MAC VU360 Resting ECG Analysis System | DPS | 2018-09-18 | View |
| 510(k) | K170155 | EK12 Algorithm | MHX | 2017-06-06 | View |
No matching devices.
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