Ge Hualun Medical Systems Co. , Ltd.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Ge Hualun Medical Systems Co. , Ltd.” (first 2015, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 56 days. Since 2017 the median was 53 days, against 100 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 |
|---|---|---|
| 2015 | 1 | 97 |
| 2016 | 0 | — |
| 2017 | 4 | 28 |
| 2018 | 1 | 53 |
| 2019 | 1 | 29 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 76 |
| 2024 | 2 | 150 |
| 2025 | 2 | 112 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ge Hualun Medical Systems Co. , Ltd. took a median 53 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 100 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | 7 | 7 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 4 | 4 |
| OWB | Interventional Fluoroscopic X-Ray System | 1 | 1 |
Review panels
- Radiology (12)
Most recent Ge Hualun Medical Systems Co. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253269 | OEC One CFD | OXO | 2025-11-26 | 58 |
| K250788 | Definium Tempo Select | KPR | 2025-08-28 | 167 |
| K240828 | OEC One ASD | OXO | 2024-12-27 | 276 |
| K242678 | Definium Pace Select ET | KPR | 2024-10-01 | 25 |
| K231892 | Definium Pace Select | KPR | 2023-09-12 | 76 |
| K191699 | Discovery XR656 HD with VolumeRad | KPR | 2019-07-24 | 29 |
| K182626 | OEC One | OXO | 2018-11-16 | 53 |
| K173612 | Optima XR646 HD | KPR | 2017-12-11 | 19 |
| K172700 | OEC One | OWB | 2017-11-09 | 63 |
| K172869 | Discovery XR656 HD | KPR | 2017-10-20 | 30 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ge Hualun Medical Systems Co. , Ltd..
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 Hualun Medical Systems Co. , Ltd.?
FDA lists 12 510(k) clearances under the applicant name “Ge Hualun Medical Systems Co. , Ltd.” (first 2015, latest 2025), across 3 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 Hualun Medical Systems Co. , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ge Hualun Medical Systems Co. , Ltd. is 56 days. Since 2017: 53 days, versus 100 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ge Hualun Medical Systems Co. , Ltd.?
The most frequent FDA product codes under this applicant name are KPR (System, X-Ray, Stationary, 7); OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile, 4); OWB (Interventional Fluoroscopic X-Ray System, 1).
Next steps
- See all 12 Ge Hualun Medical Systems Co. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KPR, Ge Hualun Medical Systems Co. , Ltd.'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.