EasyDiagnost Eleva
Table, Radiographic, Tilting
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Beijing.
| 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 |
Record
| Listed by | Philips Medical Systems DMC GmbH, Germany |
|---|---|
| FDA product code | IXR |
| Device type | Table, Radiographic, Tilting |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1980 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-19 |
| Record revised | 2021-10-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9890-010-03632 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oakworks Medical | Oakworks, Inc. | 265 |
| Image Diagnostics Inc | Image Diagnostics, Inc. | 41 |
| Aadco | Aadco Medical, Inc. | 28 |
| Medstone | Stille AB | 17 |
| Surgical C Arm Table | Biodex Medical Systems, Inc. | 12 |
| Aadco Imaging Table | Aadco Medical, Inc. | 4 |
| Sonesta | Sonesta Medical AB | 2 |
| LF | Liebel-Flarsheim Company LLC | 2 |
| Urology C Arm Table | Biodex Medical Systems, Inc. | 2 |
| Brachytherapy Table | Biodex Medical Systems, Inc. | 2 |
| ZS-100IR | Shimadzu Corp. | 2 |
| YSF-300 | Shimadzu Corp. | 2 |
Showing 12 of 22. All products under Table, Radiographic, Tilting
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Philips North America LLC | UDI-DI | 2023-09-21 | Class II | Under Investigation by firm | Potential for units suspended on the ceiling to fail and fall. | 40 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.