uDR
The uDR 380i Pro is a mobile digital radiography system for acquiring X-ray images of human anatomy for medical diagnosis. The FDA summary identifies this model for radiographic…
The uDR 380i Pro is a mobile digital radiography system for acquiring X-ray images of human anatomy for medical diagnosis. The FDA summary identifies this model for radiographic examinations of adult and pediatric patients in patient treatment areas.
The system combines an X-ray assembly, detector, motion and power components, and image acquisition software. Its mobile design supports examinations in locations such as an emergency room, intensive care unit or ward. The filing specifies use by a qualified and trained operator.
Listed Item
Mobile Digital Medical X-ray Imaging System
System Configuration
The summary lists wireless flat-panel detectors, an X-ray tube, collimator and touchscreen image-acquisition workstation. Detector formats include 14 by 17 inches and 14 by 14 inches. The filing states that the uDR 380i Pro is not intended for mammography.
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 | Shanghai United Imaging Healthcare Co., Ltd., China |
|---|---|
| FDA product code | IZL |
| Device type | System, X-Ray, Mobile |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1720 |
| Establishment | Manufacturer |
| 510(k) | K222339 |
| Record published | 2023-02-28 |
| Record revised | 2025-09-08 (version 3) |
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 |
|---|---|---|
| uDR 380i Pro | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Siui | Shantou Institute OF Ultrasonic Instruments Co., Ltd. | 27 |
| 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 |
Showing 12 of 75. All products under System, X-Ray, Mobile
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242515 | 2024-10-10 |
| K222339 | 2022-09-30 |
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.