AirRay-mini
AirRay-mini is a handheld, battery-powered X-ray generator for diagnostic imaging of adult extremities by qualified healthcare professionals. It supplies controlled radiation to a…
AirRay-mini is a handheld, battery-powered X-ray generator for diagnostic imaging of adult extremities by qualified healthcare professionals. It supplies controlled radiation to a separately cleared detector or digital radiography system. It is not intended for mammography.
The internal battery supplies an inverter that produces high voltage across the X-ray tube. Electrons travel from the cathode to the anode target, generating X-rays as they decelerate. The operator selects exposure parameters such as tube voltage, current and exposure time.
Generator Configuration
The assembly includes a control unit, high-voltage generator, X-ray tube and hand switch. The 90A and 90F models have a 90 kV peak voltage, while the 80A and 80F models have an 80 kV peak voltage. The image receptor and image-processing functions belong to the separately paired imaging system.
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 | Poskom Co., Ltd., South Korea |
|---|---|
| FDA product code | IZL |
| Device type | System, X-Ray, Mobile |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1720 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K253244 |
| Record published | 2026-04-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AirRay-mini 90F | In distribution | |
| AirRay-mini 80F | In distribution | |
| AirRay-mini 90A | In distribution | |
| AirRay-mini 80A | 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 |
|---|---|
| K253244 | 2026-02-23 |
| K250976 | 2025-12-19 |
| K222896 | 2022-12-20 |
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.