General Electric Medical Systems: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “General Electric Medical Systems” (first 2001, latest 2005), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 15 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 2 | 2 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| KPQ | System, Simulation, Radiation Therapy | 1 | 1 |
Review panels
- Radiology (6)
Most recent General Electric Medical Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K052897 | GE DEFINIUM AMX 700, MODEL AMX 700 | IZL | 2005-11-08 | 25 |
| K041521 | VOLUME VIEWER PLUS | JAK | 2004-06-22 | 14 |
| K041270 | CT COLONOGRAPHY II | LLZ | 2004-05-27 | 15 |
| K041267 | CARDIQ ANALYSIS III | JAK | 2004-05-27 | 15 |
| K021780 | ADVANTAGE SIM 6.0 | KPQ | 2002-07-29 | 60 |
| K014058 | ENTEGRA PE PERSONAL DIGITAL ASSISTANT | LLZ | 2001-12-21 | 11 |
Recalls
openFDA lists no recalls under a recalling firm named General Electric Medical Systems.
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 Electric Medical Systems Information Techn (33 510(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)
Frequently asked questions
How many FDA 510(k) clearances are listed under General Electric Medical Systems?
FDA lists 6 510(k) clearances under the applicant name “General Electric Medical Systems” (first 2001, latest 2005), across 4 product codes in 1 review panel. 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?
The median time from FDA receipt to decision across 510(k)s cleared under the name General Electric Medical Systems is 15 days.
Which FDA product codes appear under General Electric Medical Systems?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 2); LLZ (System, Image Processing, Radiological, 2); IZL (System, X-Ray, Mobile, 1).
Next steps
- See all 6 General Electric Medical Systems clearances with predicates and recalls
- Run predicate analysis for product code JAK, General Electric Medical Systems'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.