Discovery
XR656 SYS Cabinet UDI
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Beijing.
| 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 |
Record
| Listed by | Ge Hualun Medical Systems Co., Ltd., China |
|---|---|
| FDA product code | IZF |
| Device type | System, X-Ray, Tomographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1740 |
| 510(k) | K132261 |
| Record published | 2016-05-26 |
| Record revised | 2025-04-07 (version 5) |
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 |
|---|---|---|
| XR656 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nanox.ARC X | Nano-X Imaging Ltd | 1 |
| Adaptix Ortho350 | Adaptix Limited | 1 |
| TAP2D | Nano-X Imaging Ltd | 1 |
| Nanox.ARC | Nano-X Imaging Ltd | 1 |
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.