Table, Radiologic
SIGNA Premier 3.0T Detachable Table Assembly- Wireless Gating
4manufacturers in China registered for this device type
7catalogue numbers in this listing
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 | GE Medical Systems, L.L.C. |
|---|---|
| FDA product code | KXJ |
| Device type | Table, Radiologic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1980 |
| Premarket notification | Exempt |
| Record published | 2022-08-23 |
| Record revised | 2026-01-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6265300-22 | In distribution | |
| 6265300-2 | In distribution | |
| 6265300-62 | In distribution | |
| 6265300-20 | In distribution | |
| 6265300 | In distribution | |
| 9265300-3 | In distribution | |
| 6265300-60 | In distribution |
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
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| GE Medical Systems, LLC | UDI-DI | 2025-06-20 | Class II | Equipment maintenance | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET | 214 units |
| GE Medical Systems, LLC | UDI-DI | 2025-06-20 | Class II | Equipment maintenance | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET | 330 units |
| GE Medical Systems, LLC | UDI-DI | 2025-06-20 | Class II | Equipment maintenance | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET | 56 units |
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.