Micro-X
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
5manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
10recalls 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 | Micro-X Ltd, Australia |
|---|---|
| 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) | K201488 |
| Record published | 2020-08-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 30 to 60 % RH; Handling environment temperature 10 to 30 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 86 % RH; Storage environment temperature -20 to 55 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Rover | 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 |
|---|---|
| K211423 | 2021-05-21 |
| K201488 | 2020-07-17 |
Recalls
10 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-03-27 | Class II | Component design/selection | X-Ray generator may malfunction resulting in the X-Ray being inoperable. | 32 units |
| 2025-04-04 | Class II | Device Design | Potential for internal fastening mechanism within generator of mobile x-Ray to fail. | 13 units |
| 2025-04-04 | Class II | Device Design | Potential for internal fastening mechanism within generator of mobile x-Ray to fail. | 5 units |
| 2025-03-28 | Class II | Device Design | Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode. | 31 units |
| 2025-03-28 | Class II | Device Design | Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode. | 20 units |
| 2024-10-23 | Class II | Device Design | During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a very short time such t | 23 |
| 2024-10-22 | Class II | Environmental control | Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft | 6 |
| 2023-11-28 | Class II | Device Design | Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator. | 18 |
| 2023-05-31 | Class II | Software design | Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started. | 5 |
| 2022-08-31 | Class II | Process control | Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions | 42 units |
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.