Exsys DEXi
The EXSYS DEXi is a digital diagnostic X-ray system for general radiographic imaging of human anatomy. X-ray exposure and a flat panel detector produce image data, which a workstation…
The EXSYS DEXi is a digital diagnostic X-ray system for general radiographic imaging of human anatomy. X-ray exposure and a flat panel detector produce image data, which a workstation processes to display anatomical information.
The system combines an X-ray generator, tube and collimator with a tube stand, bucky stand, patient table, detector and console. These components provide the radiation source, imaging arrangement and operator interface within a complete radiographic system.
Imaging Scope
The EXSYS DEXi family includes multiple model configurations with different mechanical and imaging components. Its intended application is general purpose radiography; mammography is outside the system’s intended use.
Who Else Makes It
Concentrated in Shanghai (3), Beijing (2), Jiangsu (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 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Orich Medical Equipment (Tianjin) Co., Ltd. | Tianjin | Tianjin | Manufacturer | 5 |
Record
| Listed by | Drtech Corporation, South Korea |
|---|---|
| FDA product code | KPR |
| Device type | System, X-Ray, Stationary |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K242847 |
| Record published | 2025-03-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EXSYS DEXi-D402S-FRA | In distribution | |
| EXSYS DEXi-D402P-FRM | In distribution | |
| EXSYS DEXi-D402P-FRA | In distribution | |
| EXSYS DEXi-D401P-FRM | In distribution | |
| EXSYS DEXi-D503T-FRA | In distribution | |
| EXSYS DEXi-A401S-FRM | In distribution | |
| EXSYS DEXi-A503T-FRM | In distribution | |
| EXSYS DEXi-A401P-FRM | In distribution | |
| EXSYS DEXi-D401S-FRA | In distribution | |
| EXSYS DEXi-D401P-FRA | In distribution | |
| EXSYS DEXi-D401S-FRM | In distribution | |
| EXSYS DEXi-A402S-FRM | In distribution | |
| EXSYS DEXi-D402S-FRM | In distribution | |
| EXSYS DEXi-D503T-FRM | In distribution | |
| EXSYS DEXi-A402P-FRM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drgem | Drgem Corporation | 171 |
| Q-RAD System | Carestream Health, Inc. | 159 |
| DRX – Ascend System | Carestream Health, Inc. | 121 |
| FDR Clinica | Drgem Corporation | 41 |
| RADspeed Pro | Shimadzu Corp. | 31 |
| FDR Visionary Suite | Shimadzu Corp. | 17 |
| Del Medical, Inc. | DEL Medical, Inc. | 15 |
| GXR-Es,ecs Diagnostic X-ray System | Drgem Corporation | 14 |
| X-CEL X-RAY Corporation | Arquilla, Inc. | 14 |
| DRX-Evolution Plus System | Carestream Health, Inc. | 12 |
| Carestream DRX-Evolution | Carestream Health, Inc. | 10 |
| System, X-Ray, Stationary | Samsung Electronics Co., Ltd. | 8 |
Showing 12 of 138. All products under System, X-Ray, Stationary
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242847 | 2024-10-23 |
| K233530 | 2024-07-26 |
| K111655 | 2011-11-30 |
| K091747 | 2009-07-01 |
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.