Ge Medical Systems Information Technologies: FDA clearances and approvals
Ge Medical Systems Information Technologies has 171 FDA 510(k) clearances (first 1978, latest 2026), plus 1 PMA decision, across 36 product codes in 4 review panels. Median 510(k) review time: 84 days. Since 2017 its median was 149 days, against 153 days for all cleared 510(k)s in the same product codes. openFDA lists 29 product recalls by a recalling firm named Ge Medical Systems Information Technologies.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 264 |
| 2013 | 4 | 79 |
| 2014 | 1 | 131 |
| 2015 | 1 | 202 |
| 2016 | 1 | 91 |
| 2017 | 1 | 139 |
| 2018 | 1 | 274 |
| 2019 | 0 | — |
| 2020 | 2 | 120 |
| 2021 | 1 | 123 |
| 2022 | 6 | 158 |
| 2023 | 3 | 157 |
| 2024 | 3 | 83 |
| 2025 | 1 | 315 |
| 2026 | 2 | 270 |
Review time against the same product codes
Since 2017, Ge Medical Systems Information Technologies's cleared 510(k)s took a median 149 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 153 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 34 | 34 |
| HGM | System, Monitoring, Perinatal | 29 | 29 |
| DQK | Computer, Diagnostic, Programmable | 18 | 18 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 12 | 12 |
| DPS | Electrocardiograph | 9 | 9 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 7 | 7 |
| BZQ | Monitor, Breathing Frequency | 6 | 6 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 6 | 6 |
| ITX | Transducer, Ultrasonic, Diagnostic | 6 | 6 |
| DXQ | Blood Pressure Cuff | 4 | 4 |
Plus 26 more product codes.
Review panels
- Cardiovascular (106)
- Obstetrics and Gynecology (38)
- Radiology (15)
- Anesthesiology (12)
Most recent Ge Medical Systems Information Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | MHX | 2026-07-24 | 298 |
| K251670 | MAC 7 Resting ECG Analysis System | DPS | 2026-01-26 | 241 |
| K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | MHX | 2025-07-09 | 315 |
| K243540 | Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) | DQK | 2024-12-12 | 27 |
| K233810 | Portrait VSM | MWI | 2024-04-25 | 147 |
| 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 | 83 |
| K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System | DQK | 2023-12-13 | 170 |
| 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 | 157 |
| K230145 | ONE-CUF | DXQ | 2023-03-14 | 55 |
| K222586 | Mural Clinical Viewer | MHX | 2022-12-21 | 117 |
161 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P000016 | PMA | COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR | 2001-02-09 |
Recalls
29 product recalls in 19 recall events; 18 initiated in the last five years. Most recent: 2026-07-30.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Ge Medical Systems Information Technologies have?
Ge Medical Systems Information Technologies has 171 FDA 510(k) clearances (first 1978, latest 2026), plus 1 PMA decision, across 36 product codes in 4 review panels.
How long does FDA take to clear Ge Medical Systems Information Technologies's 510(k)s?
The median time from FDA receipt to decision across Ge Medical Systems Information Technologies's cleared 510(k)s is 84 days. Since 2017: 149 days, versus 153 days for all cleared 510(k)s in the same product codes.
What devices does Ge Medical Systems Information Technologies make?
Its most frequent FDA product codes are MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 34); HGM (System, Monitoring, Perinatal, 29); DQK (Computer, Diagnostic, Programmable, 18).
Has Ge Medical Systems Information Technologies had device recalls?
openFDA lists 29 product recalls in 19 recall events by a recalling firm whose name matches Ge Medical Systems Information Technologies; the most recent began 2026-07-30. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 171 Ge Medical Systems Information Technologies clearances with predicates and recalls
- Run predicate analysis for product code MHX, Ge Medical Systems Information Technologies's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.