Surgical C Arm Table
Table, Pain Management C-Arm, Rectangular Top, 115VAC
2manufacturers in China registered for this device type
12catalogue numbers in this listing
1510(k) clearance
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 | Biodex Medical Systems, Inc., United States |
|---|---|
| FDA product code | IXR |
| Device type | Table, Radiographic, Tilting |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1980 |
| Premarket notification | Exempt |
| Record published | 2017-12-18 |
| Record revised | 2023-07-25 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2023-07-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 058-875 | Withdrawn | |
| 058-870-10 | Withdrawn | |
| 058-847-10 | Withdrawn | |
| 058-875-10 | Withdrawn | |
| 058-840 | Withdrawn | |
| 058-846 | Withdrawn | |
| 058-845 | Withdrawn | |
| 058-870 | Withdrawn | |
| 058-847 | Withdrawn | |
| 058-840-10 | Withdrawn | |
| 058-846-10 | Withdrawn | |
| 058-845-10 | Withdrawn |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 |
| 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 |
| Sonesta F3 | Sonesta Medical AB | 2 |
Showing 12 of 22. All products under Table, Radiographic, Tilting
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K950981 | 1995-04-03 |
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.