ZiFix™
ZiFix™ Abdominal/Thoracic Motion Control System
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1), Tianjin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| GE Healthcare (Tianjin) Company Limited | Tianjin | Tianjin | Specification developer | 5 |
Record
| Listed by | Qfix, United States |
|---|---|
| FDA product code | OUO |
| Device type | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1200 |
| Record published | 2017-07-17 |
| Record revised | 2023-12-11 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 130 to 170 cm; width 13 to 20 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RT-4558CB02 | Length 170 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | GE Medical Systems, L.L.C. | 13 |
| Symphony™ | Qfix | 3 |
| Flex small 4 MR coil set 3T | Siemens Healthcare Limited | 2 |
| Lithotomy AirShuttle™ | Qfix | 1 |
| mMR Head | Siemens Healthcare Limited | 1 |
| 3T Loop 4 cm MR coil kit | Siemens Healthcare Limited | 1 |
| mMR Head set | Siemens Healthcare Limited | 1 |
| mMR Head/Neck coil set | Siemens Healthcare Limited | 1 |
| mMR Head/Neck Matrix coil | Siemens Healthcare Limited | 1 |
| mMR Body coil set | Siemens Healthcare Limited | 1 |
| uPMR | Shanghai United Imaging Healthcare Co., Ltd. | 1 |
| 3T Body Matrix MR coil set, Verio | Siemens Healthcare Limited | 1 |
Showing 12 of 22. All products under Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
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.