LF
Hydra Vision Urology System, 80 kW
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 | Liebel-Flarsheim Company LLC, United States |
|---|---|
| FDA product code | IXR |
| Device type | Table, Radiographic, Tilting |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1980 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K943581 |
| Record published | 2016-09-09 |
| Record revised | 2022-01-05 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2019-10-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 700540 | Withdrawn | |
| 700539 | Withdrawn |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 |
| 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 Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Liebel-Flarsheim Company LLC | 510(k) number | 2017-02-27 | Class II | Radiation Control for Health and Safety Act | Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than 35% from the dosimeter readings. | 313 | 2023-08-16 |
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.