Portable X-Ray Unit
AJEX1200H is a portable X-ray unit designed for ease usage. Applying high frequency inverter type X-ray generator. - X-ray tube voltage(kV) : 40 ∼ 120 kV - X-ray tube current time…
AJEX1200H is a portable X-ray unit designed for ease usage. Applying high frequency inverter type X-ray generator. – X-ray tube voltage(kV) : 40 ∼ 120 kV – X-ray tube current time product(mAs) : 0.6 ∼ 168 mAs
5manufacturers in China registered for this device type
5catalogue 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 | Ajex Meditech., Ltd., United States |
|---|---|
| FDA product code | IZL |
| Device type | System, X-Ray, Mobile |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1720 |
| 510(k) | K122298 |
| Record published | 2016-11-04 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment temperature 0 to 50 °C; Handling environment humidity 30 to 85 % RH; Handling environment temperature 5 to 40 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AJEX1200H | In distribution | |
| AJEX240H | In distribution | |
| AJEX9015H | In distribution | |
| AJEX135H | In distribution | |
| AJEX240H | 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 |
| 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 |
|---|---|
| K122298 | 2014-03-28 |
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.