Skanrad 400
Skanrad 400 is a stationary radiography system with a 32 kW high-frequency X-ray generator. It supports general X-ray examinations using a floating table for recumbent patients or a chest…
Skanrad 400 is a stationary radiography system with a 32 kW high-frequency X-ray generator. It supports general X-ray examinations using a floating table for recumbent patients or a chest stand for standing examinations.
The system combines a tube head and collimator, table, chest stand and high-voltage generator. Electronic controls and feedback circuits manage the X-ray output and operator settings.
Listed Item
Skanrad 400 is an advanced high frequency type X-ray system designed for superior image quality for radiographic use with powerful 32 kW generator and very low X-ray leakage radiation
Image Receptors
Skanrad 400 can work with conventional film, computed radiography cassettes or compatible digital radiography detectors and image-acquisition software. Digital configurations use specified wired or wireless flat panels. The system supports general anatomical imaging in adult and pediatric patients with positioning appropriate to the examination.
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 | Skanray Technologies Limited, India |
|---|---|
| FDA product code | KPR |
| Device type | System, X-Ray, Stationary |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K220518 |
| Record published | 2022-05-11 |
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 |
|---|---|---|
| 303-000783-4 | 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 |
| 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 |
Showing 12 of 138. All products under System, X-Ray, Stationary
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231761 | 2023-10-27 |
| K220518 | 2022-04-01 |
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.