Presto DR 4143optimum
Catalogue number 1004143, listed by C.M.T. Medical Technologies Ltd., under System, X-Ray, Stationary. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (3), Beijing (2), Jiangsu (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 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Orich Medical Equipment (Tianjin) Co., Ltd. | Tianjin | Tianjin | Manufacturer | 5 |
Record
| Listed by | C.M.T. Medical Technologies Ltd. |
|---|---|
| FDA product code | KPR |
| Device type | System, X-Ray, Stationary |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| 510(k) | K110849 |
| Record published | 2018-09-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1004143 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drgem | Drgem Corporation | 171 |
| Q-RAD System | Carestream Health, Inc. | 159 |
| DRX – Ascend System | Carestream Health, Inc. | 121 |
| FDR Clinica | Drgem Corporation | 41 |
| RADspeed Pro | Shimadzu Corp. | 31 |
| FDR Visionary Suite | Shimadzu Corp. | 17 |
| Exsys DEXi | Drtech Corporation | 15 |
| Del Medical, Inc. | DEL Medical, Inc. | 15 |
| GXR-Es,ecs Diagnostic X-ray System | Drgem Corporation | 14 |
| X-CEL X-RAY Corporation | Arquilla, Inc. | 14 |
| DRX-Evolution Plus System | Carestream Health, Inc. | 12 |
| Carestream DRX-Evolution | Carestream Health, Inc. | 10 |
Showing 12 of 138. All products under System, X-Ray, Stationary
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.