Adaptix Ortho350
Adaptix Ortho350 generates tomosynthesis images of extremities, upper and lower limbs, and adjacent anatomy for routine radiography examinations. The system includes a C-arm assembly and…
Adaptix Ortho350 generates tomosynthesis images of extremities, upper and lower limbs, and adjacent anatomy for routine radiography examinations.
The system includes a C-arm assembly and control PC and can also create 2D X-ray images of the selected anatomy.
Listed Item
The Adaptix Ortho350 (K252133) is a 3D tomographic X-ray device intended to generate tomosynthesis images of human anatomy for diagnostic purposes of body extremities, upper/lower limbs, and adjacent anatomy in all routine radiography examinations. The device comprises of an Ortho350 C-Arm Assembly and a Control PC. It is also possible to create 2D X-ray images of the desired anatomy. The Adaptix Ortho350 device is a portable system that can be placed on a benchtop or the floor or mounted on an optional cart for added mobility. To obtain 3D tomosynthesis images, the relevant area of the patient is positioned against the detector cover then X-rays are emitted from a controlled sequence of locations. The system uses a low-power, monoblock X-ray source with integrated controls and feedback, synchronized electronically with the detector for tomosynthesis image acquisition. The system is operated by an X-ray technologist or suitably qualified healthcare professional using and designed with safety features to only allow X-ray emission when multiple controls are in place.
Image Acquisition
For 3D tomosynthesis, the system emits X-rays from a controlled sequence of locations while the relevant anatomy is positioned against the detector cover. The portable system may be placed on a benchtop or the floor, or mounted on an optional cart.
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 | Adaptix Limited, United Kingdom |
|---|---|
| FDA product code | IZF |
| Device type | System, X-Ray, Tomographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1740 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K252133 |
| Record published | 2025-11-19 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 57 to 106 KiloPascal; Storage environment humidity 30 to 70 % RH; Storage environment temperature -10 to 55 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AD01-0850 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nanox.ARC X | Nano-X Imaging Ltd | 1 |
| Discovery | Ge Hualun Medical Systems Co., Ltd. | 1 |
| TAP2D | Nano-X Imaging Ltd | 1 |
| Nanox.ARC | Nano-X Imaging Ltd | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252133 | 2025-11-06 |
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.