DR 100s
Mobile DR
5manufacturers in China registered for this device type
1catalogue number
5recalls on this code
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 | Agfa Healthcare Inc., Canada |
|---|---|
| FDA product code | IZL |
| Device type | System, X-Ray, Mobile |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1720 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K191884 |
| Record published | 2019-09-14 |
| Record revised | 2023-07-18 (version 2) |
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 |
|---|---|---|
| 6013/100 | 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
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-01-20 | Class II | Other | The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored. | 308 | 2017-04-10 |
| 2015-05-29 | Class II | Other | When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur. | 233 units | 2017-01-18 |
| 2014-06-06 | Class II | Use error | When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings. | 216 units | 2016-06-27 |
| 2014-05-13 | Class III | Labeling mix-ups | Unit was mislabeled with a factory label showing 32 KW output power. | 1 | 2014-08-13 |
| 2013-05-15 | Class II | Under Investigation by firm | Customers could potentially experience intermittent, unintended and illogical movement when using the product. | 104 | 2014-12-31 |
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.