Drgem
*Line power rating: 100-240V~ *Max Tube voltage: 150kV
7manufacturers in China registered for this device type
171catalogue numbers in this listing
7510(k) clearances naming this product code
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 | Drgem Corporation, South Korea |
|---|---|
| FDA product code | KPR |
| Device type | System, X-Ray, Stationary |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K102408 |
| Record published | 2019-01-07 |
| Record revised | 2023-09-25 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SGXR-68SD | In distribution | |
| GXR-C40S | In distribution | |
| DIAMOND-5A | In distribution | |
| SGXR-32SD | In distribution | |
| SGXR-32SD | In distribution | |
| SGXR-40S | In distribution | |
| SGXR-82S | In distribution | |
| SGXR-68S | In distribution | |
| FDR Smart FGXR-32S | In distribution | |
| GXR-40S | In distribution | |
| GXR-C40S | In distribution | |
| SGXR-32S | In distribution | |
| DIAMOND-5A | In distribution | |
| FDR Smart FGXR-C32S | In distribution | |
| GXR-C40S | In distribution | |
| SGXR-52SD | In distribution | |
| FDR Smart FGXR-52S | In distribution | |
| FDR Smart FGXR-32S | In distribution | |
| FDR Smart FGXR-40S | In distribution | |
| DIAMOND-8A | In distribution | |
| SGXR-32SD | In distribution | |
| SGXR-32SD | In distribution | |
| GXR-U32S | In distribution | |
| FDR Smart FGXR-C32S | In distribution | |
| FDR Smart FGXR-C40S | In distribution | |
| GXR-40S | In distribution | |
| SGXR-U32SD | In distribution | |
| FDR Smart FGXR-40S | In distribution | |
| SGXR-C32SD | In distribution | |
| SGXR-32S | In distribution | |
| SGXR-U32S | In distribution | |
| SGXR-40S | In distribution | |
| SGXR-40SD | In distribution | |
| SGXR-40S | In distribution | |
| SGXR-C32SD | In distribution | |
| SGXR-32S | In distribution | |
| SGXR-68SD | In distribution | |
| FDR Smart FGXR-82S | In distribution | |
| GXR-40S | In distribution | |
| GXR-U40S | In distribution | |
| FDR Smart FGXR-32S | In distribution | |
| FDR Smart FGXR-32S | In distribution | |
| SGXR-40SD | In distribution | |
| SGXR-32S | In distribution | |
| FDR Smart FGXR-C52S | In distribution | |
| SGXR-32S | In distribution | |
| GXR-68S | In distribution | |
| FDR Smart FGXR-68S | In distribution | |
| FDR Smart FGXR-C40S | In distribution | |
| GXR-82S | In distribution | |
| SGXR-C40S | In distribution | |
| FDR Smart FGXR-40S | In distribution | |
| FDR Smart FGXR-C40S | In distribution | |
| FDR Smart FGXR-52S | In distribution | |
| GXR-40S | In distribution | |
| SGXR-C40SD | In distribution | |
| FDR Smart FGXR-C52S | In distribution | |
| FDR Smart FGXR-32S | In distribution | |
| SGXR-C52SD | In distribution | |
| SGXR-U40SD | In distribution | |
| SGXR-40S | In distribution | |
| SGXR-C40S | In distribution | |
| FDR Smart FGXR-C40S | In distribution | |
| SGXR-68S | In distribution | |
| GXR-32S | In distribution | |
| SGXR-C52S | In distribution | |
| SGXR-C32SD | In distribution | |
| FDR Smart FGXR-40S | In distribution | |
| SGXR-32S | In distribution | |
| SGXR-52SD | In distribution | |
| SGXR-82S | In distribution | |
| DIAMOND-5A | In distribution | |
| SGXR-C32S | In distribution | |
| SGXR-U40SD | In distribution | |
| SGXR-C40S | In distribution | |
| SGXR-U40S | In distribution | |
| SGXR-40SD | In distribution | |
| SGXR-32SD | In distribution | |
| SGXR-82S | In distribution | |
| SGXR-52S | In distribution | |
| GXR-C52S | In distribution | |
| SGXR-68S | In distribution | |
| FDR Smart FGXR-68S | In distribution | |
| SGXR-C40SD | In distribution | |
| GXR-82S | In distribution | |
| SGXR-82SD | In distribution | |
| GXR-U32S | In distribution | |
| FDR Smart FGXR-68S | In distribution | |
| GXR-82S | In distribution | |
| SGXR-52S | In distribution | |
| SGXR-C52S | In distribution | |
| SGXR-32S | In distribution | |
| SGXR-40S | In distribution | |
| SGXR-40SD | In distribution | |
| SGXR-52S | In distribution | |
| SGXR-82SD | In distribution | |
| SGXR-40S | In distribution | |
| GXR-32S | In distribution | |
| DIAMOND-6A | In distribution | |
| FDR Smart FGXR-C52S | In distribution | |
| GXR-C52S | In distribution | |
| SGXR-40SD | In distribution | |
| DIAMOND-6A | In distribution | |
| FDR Smart FGXR-32S | In distribution | |
| GXR-40S | In distribution | |
| SGXR-40S | In distribution | |
| GXR-C32S | In distribution | |
| SGXR-C52S | In distribution | |
| GXR-52S | In distribution | |
| FDR Smart FGXR-U40S | In distribution | |
| GXR-40S | In distribution | |
| GXR-32S | In distribution | |
| SGXR-C32SD | In distribution | |
| SGXR-40SD | In distribution | |
| FDR Smart FGXR-40S | In distribution | |
| FDR Smart FGXR-40S | In distribution | |
| GXR-32S | In distribution | |
| SGXR-40S | In distribution | |
| FDR Smart FGXR-U32S | In distribution | |
| SGXR-C32S | In distribution | |
| SGXR-40SD | In distribution | |
| SGXR-U32S | In distribution | |
| GXR-32S | In distribution | |
| SGXR-C32S | In distribution | |
| GXR-68S | In distribution | |
| GXR-40S | In distribution | |
| GXR-C52S | In distribution | |
| SGXR-32SD | In distribution | |
| FDR Smart FGXR-32S | In distribution | |
| FDR Smart FGXR-40S | In distribution | |
| GXR-C32S | In distribution | |
| SGXR-C40S | In distribution | |
| SGXR-82SD | In distribution | |
| SGXR-C40SD | In distribution | |
| SGXR-U32SD | In distribution | |
| FDR Smart FGXR-U32S | In distribution | |
| SGXR-U40S | In distribution | |
| GXR-32S | In distribution | |
| GXR-C32S | In distribution | |
| FDR Smart FGXR-C52S | In distribution | |
| FDR Smart FGXR-52S | In distribution | |
| GXR-C40S | In distribution | |
| FDR Smart FGXR-82S | In distribution | |
| FDR Smart FGXR-82S | In distribution | |
| SGXR-32SD | In distribution | |
| SGXR-32S | In distribution | |
| GXR-40S | In distribution | |
| GXR-U40S | In distribution | |
| SGXR-68SD | In distribution | |
| SGXR-C52SD | In distribution | |
| SGXR-C40SD | In distribution | |
| SGXR-C52SD | In distribution | |
| GXR-32S | In distribution | |
| FDR Smart FGXR-C32S | In distribution | |
| FDR Smart FGXR-32S | In distribution | |
| FDR Smart FGXR-U40S | In distribution | |
| SGXR-52SD | In distribution | |
| DIAMOND-8A | In distribution | |
| GXR-C32S | In distribution | |
| GXR-32S | In distribution | |
| SGXR-40SD | In distribution | |
| SGXR-C52S | In distribution | |
| GXR-68S | In distribution | |
| FDR Smart FGXR-40S | In distribution | |
| GXR-C52S | In distribution | |
| FDR Smart FGXR-C32S | In distribution | |
| SGXR-C52SD | In distribution | |
| SGXR-C32S | In distribution | |
| SGXR-32SD | In distribution | |
| GXR-52S | In distribution | |
| GXR-52S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| System, X-Ray, Stationary | Samsung Electronics Co., Ltd. | 8 |
Showing 12 of 138. All products under System, X-Ray, Stationary
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242019 | 2025-01-07 |
| K232178 | 2023-09-19 |
| K202572 | 2020-09-24 |
| K202156 | 2020-09-10 |
| K192453 | 2019-10-01 |
| K192364 | 2019-09-26 |
| K102408 | 2010-12-27 |
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.