System, Nuclear Magnetic Resonance Imaging
SIGNA Artist System Medical Device Assembly-MDR
12manufacturers in China registered for this device type
16catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (3), Beijing (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Chenguang Medical Technologies Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 2 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| 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 |
| GE Healthcare (China) Co., Ltd. – Tianjin | Tianjin | Tianjin | Specification developer | 3 |
| Shenzhen RF Tech Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 2 |
| Shanghai Chenshi Medical Instruments Co., Ltd. | Shanghai | Shanghai | Exporter | 2 |
| MRI Division, Beijing Wandong Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 1 |
| Jiangsu Magspin Instrument Co., Ltd. | Kunshan | Jiangsu | Manufacturer | 1 |
| Xingaoyi Medical Equipment Co., Ltd. | Yuyao | Zhejiang | Manufacturer | 1 |
| Sino Canada Health Engineering Research Institute (Hefei) Ltd. (Scheri) | Hefei | Anhui | Complaint-file establishment | 1 |
Record
| Listed by | GE Healthcare (Tianjin) Company Limited, China |
|---|---|
| FDA product code | LNH |
| Device type | System, Nuclear Magnetic Resonance Imaging |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1000 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K251399 |
| Record published | 2025-09-26 |
| Record revised | 2026-01-30 (version 7) |
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 |
|---|---|---|
| SIGNA Sprint | In distribution | |
| 1.5T EXPRESS COIL – 16E HEAD NECK ARRAY | In distribution | |
| SIGNA Victor | In distribution | |
| SIGNA Voyager | In distribution | |
| SIGNA Creator | In distribution | |
| SIGNA Artist | In distribution | |
| 1.5T EXPRESS COIL – 9E ANTERIOR ARRAY | In distribution | |
| SIGNA Artist | In distribution | |
| SIGNA Explorer | In distribution | |
| Upgrade Kit to SIGNA Explorer | In distribution | |
| SIGNA Creator | In distribution | |
| SIGNA Voyager | In distribution | |
| SIGNA Artist | In distribution | |
| SIGNA Explorer | In distribution | |
| SIGNA Artist | In distribution | |
| SIGNA Prime | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ingenia | Philips Medical Systems Nederland B.V. | 72 |
| System, Nuclear Magnetic Resonance Imaging | GE Medical Systems, L.L.C. | 40 |
| System, Nuclear Magnetic Resonance Imaging | Medtronic Navigation, Inc. | 23 |
| Uni-frame® Thermoplastic | Medtec LLC | 19 |
| Positioning Cushion | Medtec LLC | 18 |
| Posicast® Thermoplastic | Medtec LLC | 18 |
| Invivo | Philips DS North America LLC | 15 |
| Type-S™ Thermoplastic | Medtec LLC | 14 |
| Aperto Lucent | Fujifilm Corporation | 13 |
| MRI Integral “T” with Check Valve for Medrad® Spectris MR Injector | Bayer Medical Care Inc. | 11 |
| PPG Finger Band | IVY Biomedical Systems, Inc. | 11 |
| Vac-Lok™ Cushion | Medtec LLC | 10 |
Showing 12 of 478. All products under System, Nuclear Magnetic Resonance Imaging
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233728 | 2024-01-19 |
| K223439 | 2023-02-13 |
| K213603 | 2022-02-11 |
| K211980 | 2022-01-16 |
| K202238 | 2020-09-04 |
| K192426 | 2019-10-01 |
Recalls Naming This Product
63 recalls name this product by its own identifiers, 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 | 760 units | |
| 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 | 280 units | |
| 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 | 19 units | |
| 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 | 1372 units | |
| 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 | 758 units | |
| 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 | 330 units | |
| GE Medical Systems, LLC | 510(k) number | 2025-05-23 | Class II | Device Design | GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99 | ||
| GE Healthcare (China) Co., Ltd. | 510(k) number | 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 Healthcare (China) Co., Ltd. | 510(k) number | 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 | 22 | |
| GE Healthcare (China) Co., Ltd. | 510(k) number | 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 | 33 | |
| GE Healthcare (China) Co., Ltd. | 510(k) number | 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 | 241 | |
| GE Medical Systems, LLC | 510(k) number | 2024-10-28 | Class II | Device Design | Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. | 8 units | |
| GE Medical Systems, LLC | 510(k) number | 2024-10-28 | Class II | Device Design | Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. | 53 units | |
| GE Medical Systems, LLC | 510(k) number | 2024-10-28 | Class II | Device Design | Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. | 3 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 | 834 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 | 484 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 | 724 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 | 23 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 | 1607 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 | 1228 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 | 1528 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 | 1817 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 | 2528 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 | 308 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 | 81 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 | 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 | 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 | 72 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 | 23 units | |
| GE Medical Systems, LLC | 510(k) number | 2022-03-04 | Class II | Nonconforming Material/Component | During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury. | 18,411 systems | |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 2021-08-26 | Class II | Software design | Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. | 2 devices | 2026-05-04 |
Showing 40 of 63.
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P860010 | 1988-06-12 | INSTRUMENTARIUM ULF MR IMAGING SYSTEM | Palomex Instrumentarium Corp. |
| P860062 | 1988-05-25 | RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST | Resonex, Inc. |
| P850043 | 1987-12-30 | MAGNISCAN 5000 MRI SYSTEM | Thomson-Cgr Medical Corp. |
| P830074 | 1987-11-25 | GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS | General Electric Co. |
| P840063 | 1987-08-11 | GYROSCAN(TM) | Philips Medical Systems Technologies Ltd |
| P840007 | 1987-04-02 | GYREX, MODELS S3500 & S5000 | Elscint, Inc. |
| P830076 | 1986-10-08 | FONAR NMR WHOLE BODY SCANNER BETA 3000 | Fonar Corp. |
| P830052 | 1986-05-28 | NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 | Philips Medical Systems (Cleveland), Inc. |
| P830051 | 1986-04-30 | TESLACON(TM) NMR IMAGING SYSTEM | Technicare Corp. |
| P830053 | 1985-12-18 | DIASONICS NMR IMAGING SYSTEM | Diasonics, Inc. |
| P830081 | 1985-06-06 | MAGNETOM | Siemens Healthcare Limited |
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.