Zenition 30
The Zenition 30 with flat detector is a mobile X-ray imaging and viewing system. It is designed for medical use in healthcare facilities where X-ray imaging is needed
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Beijing (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
Record
| Listed by | Philips Medical Systems Nederland B.V., Netherlands |
|---|---|
| FDA product code | OXO |
| Device type | Image-Intensified Fluoroscopic X-Ray System, Mobile |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2024-04-23 |
| Record revised | 2024-12-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment temperature -10 to 55 °C; Handling environment humidity 20 to 90 % RH; Storage environment humidity 20 to 90 % RH; Storage environment temperature -10 to 55 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Zenition 30 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| O-ARM® | Medtronic Navigation, Inc. | 16 |
| Cios Select | Siemens Shanghai, Medical Equipment Ltd. | 3 |
| Smart-C | Turner Imaging Systems, Inc. | 3 |
| Zenition | Philips Medical Systems Nederland B.V. | 2 |
| Broach Set SPX1 | Ecential Robotics | 2 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | Ecotron Co., Ltd. | 2 |
| Flourocsan InSight | Hologic, Inc. | 2 |
| Genoray | Genoray Co., Ltd. | 2 |
| 3D Imaging Set SPX1 | Ecential Robotics | 2 |
| Discovery | GE Medical Systems, LLC | 2 |
| OEC | Ge Hualun Medical Systems Co., Ltd. | 2 |
| Cios Alpha | Siemens Healthcare Limited | 1 |
Showing 12 of 40. All products under Image-Intensified Fluoroscopic X-Ray System, Mobile
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.