Ge Oec Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Ge Oec Medical Systems, Inc.” (first 2001, latest 2024), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 78 days. Since 2017 the median was 85 days, against 108 days for all cleared 510(k)s in the same product codes. 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 | 1 | 304 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 78 |
| 2018 | 0 | — |
| 2019 | 1 | 38 |
| 2020 | 0 | — |
| 2021 | 1 | 112 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 134 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ge Oec Medical Systems, Inc. took a median 85 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | 10 | 10 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 6 | 6 |
| IZI | System, X-Ray, Angiographic | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
Review panels
- Radiology (18)
Most recent Ge Oec Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233669 | OEC 3D | OXO | 2024-03-28 | 134 |
| K203346 | OEC 3D | OXO | 2021-03-05 | 112 |
| K192819 | OEC Elite | OXO | 2019-11-08 | 38 |
| K172550 | OEC Elite | OXO | 2017-11-16 | 85 |
| K171565 | OEC Elite | OWB | 2017-08-10 | 72 |
| K132027 | OEC 9800 PLUS | OWB | 2014-05-01 | 304 |
| K111551 | OEC(R) 9800, OEC(R) 9800 PLUS | OWB | 2011-10-04 | 123 |
| K073543 | OEC 9900 ELITE | OWB | 2008-05-02 | 137 |
| K061953 | 9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS | OWB | 2006-08-15 | 36 |
| K052039 | GE OEC ALTITUDE | IZI | 2005-08-11 | 14 |
8 earlier clearances. See the full list in Caduvo.
Recalls
93 product recalls in 48 recall events; 9 initiated in the last five years. Most recent: 2024-11-21.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ge Oec Medical Systems, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Ge Oec Medical Systems, Inc.” (first 2001, latest 2024), 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 Ge Oec Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ge Oec Medical Systems, Inc. is 78 days. Since 2017: 85 days, versus 108 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ge Oec Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are OWB (Interventional Fluoroscopic X-Ray System, 10); OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile, 6); IZI (System, X-Ray, Angiographic, 1).
Next steps
- See all 18 Ge Oec Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OWB, Ge Oec Medical Systems, Inc.'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.