Ge Dec Medical Systems: FDA clearances and approvals
Ge Dec Medical Systems has 10 FDA 510(k) clearances (first 1994, latest 2000), across 3 product codes in 1 review panel. Median 510(k) review time: 70 days.
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 |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | 5 | 5 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 3 | 3 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 2 | 2 |
Review panels
- Radiology (10)
Most recent Ge Dec Medical Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000221 | SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM | OWB | 2000-04-11 | 78 |
| K993687 | UROVIEW 2800 | OWB | 1999-12-21 | 50 |
| K992506 | MINI 6800 DIGITAL MOBILE C-ARM | OXO | 1999-08-19 | 23 |
| K974355 | INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS) | OWB | 1998-02-17 | 90 |
| K970063 | SERIES 7600 MOBILE DIGITAL C-ARM | OWB | 1997-03-11 | 63 |
| K963952 | SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM | OWB | 1996-12-23 | 82 |
| K950781 | COMPACT 7600 | JAA | 1995-06-05 | 104 |
| K951765 | SERIES 6600 DIGITAL MOBILE C-ARM | OXO | 1995-05-11 | 24 |
| K940295 | UROVIEW MODEL 2600 | JAA | 1994-08-22 | 213 |
| K936136 | UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE | JAA | 1994-01-25 | 34 |
Recalls
openFDA lists no recalls under a recalling firm named Ge Dec Medical Systems.
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 Dec Medical Systems have?
Ge Dec Medical Systems has 10 FDA 510(k) clearances (first 1994, latest 2000), across 3 product codes in 1 review panel.
How long does FDA take to clear Ge Dec Medical Systems's 510(k)s?
The median time from FDA receipt to decision across Ge Dec Medical Systems's cleared 510(k)s is 70 days.
What devices does Ge Dec Medical Systems make?
Its most frequent FDA product codes are OWB (Interventional Fluoroscopic X-Ray System, 5); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 3); OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile, 2).
Has Ge Dec Medical Systems had device recalls?
openFDA lists no recalls under a recalling firm name matching Ge Dec Medical Systems. Related entities may recall under other names.
Next steps
- See all 10 Ge Dec Medical Systems clearances with predicates and recalls
- Run predicate analysis for product code OWB, Ge Dec Medical Systems'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.