Siui
Portable DR Imaging System
5manufacturers in China registered for this device type
27catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Beijing (2), Shanghai (1), Guangdong (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 |
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
| Suzhou Powersite Electric Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Shantou Institute OF Ultrasonic Instruments Co., Ltd., China |
|---|---|
| FDA product code | IZL |
| Device type | System, X-Ray, Mobile |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1720 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K202353 |
| Record published | 2021-01-09 |
| Record revised | 2026-07-10 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SR-2300 | In distribution | |
| SR-8210S | In distribution | |
| SR-2100S | In distribution | |
| SR-1000S | In distribution | |
| SR-2100 | In distribution | |
| SR-1100S | In distribution | |
| SR-100Pro | In distribution | |
| SR-8000 | In distribution | |
| SR-8230 | In distribution | |
| SR-2300S | In distribution | |
| SR-200Pro | In distribution | |
| SR-1000 | In distribution | |
| SR-8000S | In distribution | |
| SR-1000Pro | In distribution | |
| SR-8230S | In distribution | |
| SR-1100Pro | In distribution | |
| SR-200 | In distribution | |
| SR-8210 | In distribution | |
| SR-2000 | In distribution | |
| SR-2300T | In distribution | |
| SR-8100S | In distribution | |
| SR-2300Pro | In distribution | |
| SR-1100 | In distribution | |
| SR-300 | In distribution | |
| SR-300Pro | In distribution | |
| SR-100 | In distribution | |
| SR-8100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AcuityPDR | RadmediX, LLC | 24 |
| Sedecal | Sedecal., Sa. | 20 |
| Drgem | Drgem Corporation | 10 |
| DRX-Revolution Mobile X-ray System | Carestream Health, Inc. | 7 |
| MinXray | Minxray, Inc. | 6 |
| System, X-Ray, Mobile | Ecotron Co., Ltd. | 6 |
| MobileDaRt Evolution | Shimadzu Corp. | 5 |
| Nomad MD™ handheld X-ray system | Aribex, Inc. | 5 |
| Portable X-ray Unit | Ajex Meditech., Ltd. | 5 |
| Diagnostic X-ray Unit | Poskom Co., Ltd. | 4 |
| FDR Aqro | Fujifilm Corporation | 4 |
| Optima | GE Medical Systems, L.L.C. | 4 |
Showing 12 of 75. All products under System, X-Ray, Mobile
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253058 | 2026-06-18 |
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.