GXR-Es,ecs Diagnostic X-Ray System
GXR-ES/ECS is a diagnostic radiography system comprising a high-voltage generator, X-ray tube, beam-limiting device and tube support. A patient table and wall Bucky stand provide…
GXR-ES/ECS is a diagnostic radiography system comprising a high-voltage generator, X-ray tube, beam-limiting device and tube support. A patient table and wall Bucky stand provide positioning options for image acquisition.
The console controls exposure factors, collimation size and filter selection. Compatible external flat-panel detectors receive the image but are separate from the system. Console options include a graphic LCD with membrane switches or a touchscreen interface.
Listed Item
The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device Identifier) is assigned based on the system model name, power specifications, and maximum x-ray tube voltage of the x-ray tube. *Power Specification (V) / maximum tube Voltage (kV) : 200-240 V~ / 125kV
Exposure Control and Calibration
The high-frequency generator provides anatomical programming and optional automatic exposure control. Automatic, semiautomatic and manual calibration functions are available. The console can display exposure waveforms and data, while system diagnostics show error codes and operating information. Configuration and available controls depend on the selected model.
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 | Drgem Corporation, South Korea |
|---|---|
| FDA product code | KPR |
| Device type | System, X-Ray, Stationary |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K232178 |
| Record published | 2023-10-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GXR-E40S | In distribution | |
| GXR-EC25S | In distribution | |
| GXR-EC20S | In distribution | |
| GXR-E25S | In distribution | |
| GXR-EC32S | In distribution | |
| GXR-E20S | In distribution | |
| GXR-E32S | In distribution | |
| GXR-EC50S | In distribution | |
| GXR-EC32S | In distribution | |
| GXR-EC20S | In distribution | |
| GXR-EC40S | In distribution | |
| GXR-EC40S | In distribution | |
| GXR-EC25S | In distribution | |
| GXR-EC50S | 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 |
| Exsys DEXi | Drtech Corporation | 15 |
| Del Medical, Inc. | DEL Medical, Inc. | 15 |
| 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 |
|---|---|
| K242019 | 2025-01-07 |
| K232178 | 2023-09-19 |
| K202572 | 2020-09-24 |
| K202156 | 2020-09-10 |
| K192453 | 2019-10-01 |
| K192364 | 2019-09-26 |
| K102408 | 2010-12-27 |
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.