Sonesta
2 catalogue numbers from 6210, listed by Sonesta Medical AB, Sweden, under Table, Radiographic, Tilting. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
1recall
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 | Sonesta Medical AB, Sweden |
|---|---|
| FDA product code | IXR |
| Device type | Table, Radiographic, Tilting |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1980 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-06-14 |
| Record revised | 2025-09-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-09-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6210 | In distribution | |
| SST | Withdrawn |
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 |
| 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 |
| Sonesta F3 | Sonesta Medical AB | 2 |
Showing 12 of 22. All products under Table, Radiographic, Tilting
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-08-22 | Class II | Process control | Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping. | 10 tables |
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.