Ge Hualun Medical Systems Co., Ltd.
Brand owner, China. 32 products catalogued, 12 clearances.
Ge Hualun Medical Systems Co., Ltd. holds an FDA establishment registration in China. Its registration names no device type; it is in this index because it catalogues devices under its own name. 31 of its products are catalogued under its own name.
32products catalogued under its own name
12510(k) clearances
Registration
| Registered name | Ge Hualun Medical Systems Co. , Ltd. |
|---|---|
| Status | Not current |
| DUNS | 554408665 |
Location
| Country | China |
|---|
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Holder, Radiographic Cassette, Wall-Mounted | IXY | 8 |
| OEC | JAA | 4 |
| Definium | KPR | 4 |
| Tube Mount, X-Ray, Diagnostic | IYB | 4 |
| System, X-Ray, Stationary | KPR | 3 |
| Definium | MQB | 3 |
| Discovery | KPR | 3 |
| Table, Radiographic, Non-Tilting, Powered | IZZ | 3 |
| Optima | IZI | 2 |
| Optima | KPR | 2 |
| Support, Patient Position | CCX | 2 |
| Optima | MQB | 2 |
| OEC | OWB | 2 |
| OEC | OXO | 2 |
| FlashPad | MQB | 2 |
| Brivo | KPR | 1 |
| Flashpad HD | MQB | 1 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 1 |
| D630 to D670 DR Upgrade | KPS | 1 |
| Brivo | KPS | 1 |
| Wireless DR Imaging Option | MQB | 1 |
| Proteus | KPR | 1 |
| System, X-Ray, Tomography, Computed | JAK | 1 |
| Discovery | IZF | 1 |
| Table, Radiographic, Tilting | IXR | 1 |
| Optima | JAA | 1 |
| Discovery | MQB | 1 |
| Optima | OWB | 1 |
| D630 Upgrade | KPS | 1 |
| Brivo 615 | JAK | 1 |
| Revolution | JAK | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253269 | 2025-11-26 | OXO | Traditional | This company |
| K250788 | 2025-08-28 | KPR | Traditional | This company |
| K240828 | 2024-12-27 | OXO | Traditional | This company |
| K242678 | 2024-10-01 | KPR | Special | This company |
| K231892 | 2023-09-12 | KPR | Traditional | This company |
| K191699 | 2019-07-24 | KPR | Traditional | This company |
| K182626 | 2018-11-16 | OXO | Traditional | This company |
| K173612 | 2017-12-11 | KPR | Special | This company |
| K172700 | 2017-11-09 | OWB | Traditional | This company |
| K172869 | 2017-10-20 | KPR | Special | This company |
| K171800 | 2017-07-12 | OXO | Special | This company |
| K143270 | 2015-02-18 | KPR | Traditional | This company |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.