Couchtop Panel
Reusable non-sterile solid couchtop panel for use with Siemens ZXT or Z4 systems
4manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Beijing (1), Shanghai (1), Tianjin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| GE Healthcare (Tianjin) Company Limited | Tianjin | Tianjin | Specification developer | 5 |
| Baxter Medical Systems (Suzhou) Co., Ltd. | Taicang | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Medtec LLC, United States |
|---|---|
| FDA product code | KXJ |
| Device type | Table, Radiologic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1980 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K950068 |
| Record published | 2017-08-02 |
| Record revised | 2020-01-02 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Special storage condition: Keep away from sunlight; Storage environment temperature 52 to 85 °F |
| Sizes | Length 79.4 cm; width 49.1 cm |
| Distribution end date | 2020-01-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MTZXTZ44069CF | Length 79.4 cm | Withdrawn |
| MTZXTZ44069CS | Length 79.4 cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tidi | Tidi Products, LLC | 1,329 |
| Table, Radiologic | Domico Med-Device, LLC | 351 |
| Hillrom™ | Baxter Medical Systems GmbH + Co. KG | 167 |
| Trumpf Medical | Baxter Medical Systems GmbH + Co. KG | 118 |
| Scancoat | Domico Med-Device, LLC | 82 |
| Gems | Tidi Products, LLC | 71 |
| Pads | Baxter Medical Systems GmbH + Co. KG | 41 |
| Bone Foam | Tidi Products, LLC | 25 |
| TS 7500 | Baxter Medical Systems GmbH + Co. KG | 21 |
| Orthopedic Extension | Baxter Medical Systems GmbH + Co. KG | 19 |
| Bionix | Tidi Products, LLC | 16 |
| Control Units | Baxter Medical Systems GmbH + Co. KG | 11 |
Showing 12 of 107. All products under Table, Radiologic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K950068 | 1995-04-06 |
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.