Ingenia 1.5t CX
Catalogue number 781262, listed by Philips Medical Systems Nederland B.V., Netherlands, under System, Nuclear Magnetic Resonance Spectroscopic. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Tianjin (2), Beijing (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| GE Healthcare (Tianjin) Company Limited | Tianjin | Tianjin | Specification developer | 5 |
| GE Healthcare (China) Co., Ltd. – Tianjin | Tianjin | Tianjin | Specification developer | 3 |
Record
| Listed by | Philips Medical Systems Nederland B.V., Netherlands |
|---|---|
| FDA product code | LNI |
| Device type | System, Nuclear Magnetic Resonance Spectroscopic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1000 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-23 |
| Record revised | 2023-09-26 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 781262 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| System, Nuclear Magnetic Resonance Spectroscopic | GE Healthcare (Tianjin) Company Limited | 6 |
| Ingenia | Philips Medical Systems Nederland B.V. | 3 |
| System, Nuclear Magnetic Resonance Spectroscopic | Usa Instruments, Inc. | 2 |
| Magnetom Cima.X | Siemens Healthcare Limited | 2 |
| Magnetom Altea | Siemens Healthineers AG | 2 |
| 1.5T 32-ch Head Coil MR Coil | Siemens Healthcare Limited | 1 |
| CP Flex Coil Large 63 047 | Siemens Healthcare Limited | 1 |
| Magnetom Sola | Siemens Healthineers AG | 1 |
| Hitachi | Hitachi, Ltd. | 1 |
| Breast Array CPL. 047 | Siemens Healthcare Limited | 1 |
| Achieva | Philips Medical Systems Nederland B.V. | 1 |
| 1.5T Loop 7 cm MR coil kit | Siemens Healthcare Limited | 1 |
Showing 12 of 85. All products under System, Nuclear Magnetic Resonance Spectroscopic
Recalls Naming This Product
5 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Philips North America LLC | UDI-DI | 2026-04-14 | Class II | Under Investigation by firm | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol display | 1 unit |
| Philips North America LLC | UDI-DI | 2025-05-13 | Class II | Software design | Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. | 9 units (OUS Only) |
| Philips North America LLC | UDI-DI | 2024-05-03 | Class II | Under Investigation by firm | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s technical room, resulting in Smoke and/or fire | |
| Philips North America LLC | UDI-DI | 2024-01-03 | Class II | Process control | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lace | 0 US; 146 OUS |
| Philips North America LLC | UDI-DI | 2023-10-23 | Class II | Under Investigation by firm | Potential component failure in the Gradient Coil could product smoke and/or fire. | 48 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.