General Electric Medical Systems Information Techn: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “General Electric Medical Systems Information Techn” (first 1999, latest 2002), across 14 product codes in 5 review panels. Median 510(k) review time under this name: 87 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under GE HealthCare, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 7 | 7 |
| DQK | Computer, Diagnostic, Programmable | 5 | 5 |
| DSI | Detector And Alarm, Arrhythmia | 5 | 5 |
| MSX | System, Network And Communication, Physiological Monitors | 3 | 3 |
| DPS | Electrocardiograph | 2 | 2 |
| HGM | System, Monitoring, Perinatal | 2 | 2 |
| LOS | 2 | 2 | |
| DQA | Oximeter | 1 | 1 |
| DSB | Plethysmograph, Impedance | 1 | 1 |
| DXJ | Display, Cathode-Ray Tube, Medical | 1 | 1 |
Plus 4 more product codes.
Review panels
- Cardiovascular (26)
- Obstetrics and Gynecology (2)
- Anesthesiology (1)
- Neurology (1)
- Radiology (1)
Most recent General Electric Medical Systems Information Techn 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023380 | T-WAVE ALTERMANS (TWA) ALGORITHM OPTION | DQK | 2002-12-03 | 56 |
| K021470 | SEER LIGHT COMPACT DIGITAL HOLTER RECORDER | MWJ | 2002-11-14 | 190 |
| K023100 | ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS | LLZ | 2002-10-11 | 23 |
| K021454 | UNITY NETWORK ID | MWI | 2002-10-01 | 148 |
| K020290 | DASH 3000/4000 PATIENT MONITOR | MHX | 2002-08-14 | 198 |
| K021366 | MAC-LAB/CARDIOLAB EP/COMBOLAB | DQK | 2002-07-03 | 64 |
| K020661 | UNITY IS PATIENT VIEWER | MSX | 2002-05-24 | 84 |
| K021325 | MODIFICATION OF APEXPRO TELEMETRY SYSTEM | MHX | 2002-05-07 | 11 |
| K020524 | PATIENTNET MONITORING SYSTEM | MSX | 2002-03-20 | 29 |
| K012467 | SOLAR 8000M SYSTEM | DSI | 2002-02-11 | 194 |
23 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named General Electric Medical Systems Information Techn.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- General Electric Co. (254 510(k)s)
- General Diagnostics (39 510(k)s)
- General Biometrics, Inc. (23 510(k)s)
- General Medical Co. (15 510(k)s)
- General Surgical Innovations (14 510(k)s)
- General X-Ray, Inc. (14 510(k)s)
- General Devices (13 510(k)s)
- General Physiotherapy, Inc. (9 510(k)s)
- General Medical Merate S.P.A (7 510(k)s)
- General Theraphysical, Inc. (7 510(k)s)
- General Atomics (6 510(k)s)
- General Electric Medical Systems (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under General Electric Medical Systems Information Techn?
FDA lists 33 510(k) clearances under the applicant name “General Electric Medical Systems Information Techn” (first 1999, latest 2002), across 14 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by General Electric Medical Systems Information Techn?
The median time from FDA receipt to decision across 510(k)s cleared under the name General Electric Medical Systems Information Techn is 87 days.
Which FDA product codes appear under General Electric Medical Systems Information Techn?
The most frequent FDA product codes under this applicant name are MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 7); DQK (Computer, Diagnostic, Programmable, 5); DSI (Detector And Alarm, Arrhythmia, 5).
Next steps
- See all 33 General Electric Medical Systems Information Techn clearances with predicates and recalls
- Run predicate analysis for product code MHX, General Electric Medical Systems Information Techn's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.