GE Hualun Medical Systems Co., Ltd.
Beijing, CN
Ge Hualun Medical Systems Co. , Ltd. appears in FDA device records in Beijing, CN. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for GE Hualun Medical Systems Co., Ltd. between 2015 and 2025. The busiest year on record is 2017, with 4. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2017 | 4 |
| 2018 | 1 |
| 2019 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253269 | OEC One CFD | OXO | Substantially Equivalent | |
| K250788 | Definium Tempo Select | KPR | Substantially Equivalent | |
| K240828 | OEC One ASD | OXO | Substantially Equivalent | |
| K242678 | Definium Pace Select ET | KPR | Substantially Equivalent | |
| K231892 | Definium Pace Select | KPR | Substantially Equivalent | |
| K191699 | Discovery XR656 HD with VolumeRad | KPR | Substantially Equivalent | |
| K182626 | OEC One | OXO | Substantially Equivalent | |
| K173612 | Optima XR646 HD | KPR | Substantially Equivalent | |
| K172700 | OEC One | OWB | Substantially Equivalent | |
| K172869 | Discovery XR656 HD | KPR | Substantially Equivalent | |
| K171800 | OEC Elite MiniView | OXO | Substantially Equivalent | |
| K143270 | Optima XR646 | KPR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain