Nanox.ARC X
Catalogue number Nanox.ARC X, listed by Nano-X Imaging Ltd, Israel, under System, X-Ray, Tomographic. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
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 | Nano-X Imaging Ltd, Israel |
|---|---|
| FDA product code | IZF |
| Device type | System, X-Ray, Tomographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1740 |
| Establishment | Manufacturer |
| Record published | 2025-09-04 |
| Record revised | 2025-12-01 (version 2) |
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 |
|---|---|---|
| Nanox.ARC X | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Discovery | Ge Hualun Medical Systems Co., Ltd. | 1 |
| Adaptix Ortho350 | Adaptix Limited | 1 |
| TAP2D | Nano-X Imaging Ltd | 1 |
| Nanox.ARC | Nano-X Imaging Ltd | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252649 | 2026-02-02 |
| K250850 | 2025-04-16 |
| K242395 | 2024-12-04 |
| K222934 | 2023-04-28 |
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.