Image-Intensified Fluoroscopic X-Ray System, Mobile
1. Line Voltage: 220~230V, 50/60Hz 2. Output Power: 5.0kW 3. Fluoroscopy Mode - F-mode: 0.5~10mA - P-mode: 0.5~20mA - Boost mode: 30mA - DS mode: 10~30mA 4. Radiography Mode - kV range:…
1. Line Voltage: 220~230V, 50/60Hz 2. Output Power: 5.0kW 3. Fluoroscopy Mode – F-mode: 0.5~10mA – P-mode: 0.5~20mA – Boost mode: 30mA – DS mode: 10~30mA 4. Radiography Mode – kV range: 40~125kV, mA range: 20~100mA, mAs range: 0.8~200mAs 5. X-ray Tube – XRR-2551(Rotating Type), Focal Spot: 0.3/0.6, Target Angle: 10degree, Anode Heat Storage: 210kHU 6. Detector – VIVIX-D 1212G (VIEWORKS), 12 x 12 inch
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 | Ecotron Co., Ltd., South Korea |
|---|---|
| FDA product code | OXO |
| Device type | Image-Intensified Fluoroscopic X-Ray System, Mobile |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Establishment | Manufacturer |
| 510(k) | K180473 |
| Record published | 2018-03-29 |
| Record revised | 2018-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 75 % RH; Storage environment temperature -10 to 70 °C; Storage environment humidity 5 to 95 % RH |
| Sizes | Weight 250 kg; width 800 mm; length 1852 mm; height 1650 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Anyview-240DR | Weight 250 kg | In distribution |
| Anyview-500DR | Weight 250 kg | 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 |
| 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 |
| System, X-RAY, Fluoroscopic, Image-Intensified | Gemss Medical Systems Co., Ltd. | 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.