System, Nuclear Magnetic Resonance Spectroscopic
SIGNA Artist Evo System Medical Device, MDR
4manufacturers in China registered for this device type
6catalogue numbers in this listing
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 | GE Healthcare (Tianjin) Company Limited, China |
|---|---|
| FDA product code | LNI |
| Device type | System, Nuclear Magnetic Resonance Spectroscopic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1000 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K213603 |
| Record published | 2022-09-08 |
| Record revised | 2026-01-30 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SIGNA Artist Evo | In distribution | |
| SIGNA Prime Elite | In distribution | |
| EXPRESS COIL – ANTERIOR ARRAY | In distribution | |
| SIGNA Champion | In distribution | |
| EXPRESS COIL – HEAD NECK ARRAY | In distribution | |
| EXPRESS COIL – POSTERIOR ARRAY | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| PA 36 MR coil set 3T 098 | Siemens Healthcare Limited | 1 |
Showing 12 of 85. All products under System, Nuclear Magnetic Resonance Spectroscopic
Recalls Naming This Product
8 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GE Medical Systems, LLC | 510(k) number | 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 | 138 units | |
| GE Healthcare (China) Co., Ltd. | UDI-DI | 2025-01-31 | Class II | Software design | For certain MR systems, a scan can be resumed following a Power Monitor trip when the “6-minute average SAR” is above the limit indicated on the “SAR Display”. The user interface may incorrectly enable a scan to proceed earlier than intende | 2538 | |
| GE Medical Systems, LLC | 510(k) number | 2024-06-14 | Class II | Device Design | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR | 375 units | |
| GE Medical Systems, LLC | 510(k) number | 2024-06-14 | Class II | Device Design | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR | 469 units | |
| GE Medical Systems, LLC | 510(k) number | 2021-12-23 | Class II | Process control | The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. | 17,228 devices total in this field correction | |
| GE Medical Systems, LLC | 510(k) number | 2017-05-11 | Class II | Mixed-up of materials/components | Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard. | 68 units in total | 2020-09-09 |
| GE Medical Systems, LLC | 510(k) number | 2012-06-08 | Class II | Software design | GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of o | 864 (57 US; 802 OUS) | 2014-11-03 |
| GE Medical Systems, LLC | 510(k) number | 2010-11-09 | Not classified | Nonconforming Material/Component | GE Healthcare has become aware of a potential issue associated with the gradient cables being inadvertently swapped while servicing the gradients on some GE Healthcare MR Systems that may impact patient safety. If the gradient cables are in | 67 | 2012-07-03 |
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.
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