DuraDiagnost
DuraDiagnost is a digital radiography system for generating X-ray images of human anatomy. The filing describes examinations of sitting, standing or lying patients by a qualified or trained…
DuraDiagnost is a digital radiography system for generating X-ray images of human anatomy. The filing describes examinations of sitting, standing or lying patients by a qualified or trained doctor or technician.
The system includes an X-ray assembly and image workstation for post-processing, storage and viewing. The source says images can be transferred through a DICOM network for printing, storage and review.
Listed Item
Stationary x-ray system
Image Workflow
The FDA summary describes digital radiography components and workstation functions. The stated use is radiographic imaging of human anatomy by trained personnel.
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 | Philips Healthcare (Suzhou) Co., Ltd., China |
|---|---|
| FDA product code | KPR |
| Device type | System, X-Ray, Stationary |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K201640 |
| Record published | 2020-09-04 |
| Record revised | 2025-07-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | serial number |
| Storage | Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 30 to 75 % RH; Handling environment temperature 18 to 30 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 95 % RH; Storage environment temperature -10 to 55 °C |
| Distribution end date | 2024-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DuraDiagnost | Withdrawn |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201640 | 2020-07-09 |
| K163410 | 2017-01-04 |
| K141381 | 2014-06-12 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Philips North America LLC | 510(k) number | 2025-03-10 | Class II | Under Investigation by firm | Potential for collimator to fall as a result of incorrect installation. | 83 units |
| Philips North America LLC | 510(k) number | 2025-03-10 | Class II | Under Investigation by firm | Potential for collimator to fall as a result of incorrect installation. | 83 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.