Oakworks Medcal
CFLU401 with Foot Control + 2" Table Top Pad + 5" Casters + Directional Locking Casters + Extension End Support (Tower) 23 x 20
2manufacturers in China registered for this device type
1catalogue number
2recalls on this code
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 | Oakworks, Inc., United States |
|---|---|
| FDA product code | IXR |
| Device type | Table, Radiographic, Tilting |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1980 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2025-12-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-12-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CFLU401 | Withdrawn |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 |
| 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
2 of these are 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 | Closed |
|---|---|---|---|---|---|
| 2019-05-02 | Class II | Nonconforming Material/Component | Table assembly error with incorrect actuators for the lateral and longitudinal table movements | 3 units | 2019-07-08 |
| 2017-07-31 | Class II | Device Design | The foot control used on the OAKWORKS Inc., CFPM300, CFPM301, CFPM400, CFPM401, CFPMB301, CFUR301, CFUR401 and CFLU401 Imaging Tables can become lodged under the base or under the column of the table. | 1,104 | 2019-03-29 |
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.