Smart-C
Smart-C is a portable, battery-powered mini C-arm for real-time fluoroscopic imaging of adult and pediatric limbs, extremities and shoulders. It supports diagnostic, treatment and surgical…
Smart-C is a portable, battery-powered mini C-arm for real-time fluoroscopic imaging of adult and pediatric limbs, extremities and shoulders. It supports diagnostic, treatment and surgical procedures, including orthopedic and emergency use.
A CMOS flat-panel detector aligns with an X-ray source, while images transfer wirelessly to a tablet workstation. A wireless foot switch initiates acquisition, and the system includes battery packs, charger and tablet dock.
Support and Display Options
The C-arm operates on a table or another hard, flat surface or an optional support stand. An optional battery-powered monitor cart adds a 27 inch touchscreen, keyboard, printer and battery charger.
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 | Turner Imaging Systems, Inc., United States |
|---|---|
| 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, Manufacturer |
| 510(k) | K190024 |
| Record published | 2020-07-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Smart-C Mini C-Arm Imaging System | In distribution | |
| Support Stand for Smart-C | In distribution | |
| Monitor Cart for Smart-C | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| O-ARM® | Medtronic Navigation, Inc. | 16 |
| Cios Select | Siemens Shanghai, Medical Equipment Ltd. | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190024 | 2019-09-27 |
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.