Manufacturer
Ge Hangwei Medical Systems
ChinaLegal entities : GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Markets : Austria · Belgium · Denmark · France · Germany · Greece · Italy · Portugal · Spain · United States
Approvals : EU – class IIa, IIb · United States (FDA) – 510(k) : 10 · class II · latest in 2024 · see on the FDA website
EU representative : GE Medical Systems SCS (France)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a category to see competitors, a model to open its EUDAMED record.
| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Computed tomographs - 16 layers or more but less than 64 layers | Z11030603 |
2 others |
IIb MDR, 93/42 | EUDAMED record Report an error |
| Computed tomographs - 128 layers or more but less than 256 layers | Z11030606 | IIb MDR | EUDAMED record Report an error | |
| Computed tomographs (CT) - medical device software | Z11030692 | IIa MDR | EUDAMED record Report an error | |
| Computed tomographs - 256 layers or more | Z11030607 |
|
IIb MDR | EUDAMED record Report an error |
| Computed tomographs - 64 layers or more but less than 128 layers | Z11030605 | IIb MDR | EUDAMED record Report an error |
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