Drgem
220-230VAC, 550VA
3manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Beijing (2), Shanghai (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 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
Record
| Listed by | Drgem Corporation, South Korea |
|---|---|
| FDA product code | IZZ |
| Device type | Table, Radiographic, Non-Tilting, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1980 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-05-29 |
| Record revised | 2019-10-28 (version 3) |
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 |
|---|---|---|
| PBT-6 | In distribution | |
| aaa | In distribution | |
| PBT-1 | In distribution | |
| PBT-4 | In distribution | |
| PBT-6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Image Diagnostics Inc | Image Diagnostics, Inc. | 12 |
| Summit Radiographic table | Summit Industries, LLC | 4 |
| Del Medical Inc. | DEL Medical, Inc. | 4 |
| Table, Radiographic, Non-Tilting, Powered | GE Hangwei Medical Systems Co., Ltd. | 3 |
| Oakworks Medical | Oakworks, Inc. | 3 |
| Table, Radiographic, Non-Tilting, Powered | Ge Hualun Medical Systems Co., Ltd. | 3 |
| CombiMax | Pausch, L.L.C. | 2 |
| QT-750 | Carestream Health, Inc. | 2 |
| DRX – Ascend System | Carestream Health, Inc. | 1 |
| Table, Radiographic, Non-Tilting, Powered | GE Healthcare Japan Corporation | 1 |
| QT-730 | Carestream Health, Inc. | 1 |
| Sedecal | Sedecal., Sa. | 1 |
Showing 12 of 19. All products under Table, Radiographic, Non-Tilting, Powered
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.