Diagnostic X-Ray Unit
4 catalogue numbers from PXM-20BT PLUS, listed by Poskom Co., Ltd., South Korea, under System, X-Ray, Mobile. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
4catalogue numbers in this listing
3510(k) clearances naming this product 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 | 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) | K032628 |
| Record published | 2018-06-15 |
| Record revised | 2023-06-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PXM-20BT PLUS | In distribution | |
| PXP-100CA | In distribution | |
| PXM-20HF PLUS | In distribution | |
| PXM-40BT PLUS | 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 |
| 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 |
|---|---|
| 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.