Vantage Titan 3t
Catalogue number MRT-3010, listed by Canon Inc., Japan, under System, Nuclear Magnetic Resonance Imaging. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
1catalogue number
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 | Canon Inc., Japan |
|---|---|
| FDA product code | LNH |
| Device type | System, Nuclear Magnetic Resonance Imaging |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1000 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K113093 |
| Record published | 2016-09-01 |
| Record revised | 2026-03-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MRT-3010 | 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 |
| System, Nuclear Magnetic Resonance Imaging | GE Healthcare (Tianjin) Company Limited | 16 |
| 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 |
Showing 12 of 478. All products under System, Nuclear Magnetic Resonance Imaging
Recalls Naming This Product
5 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 |
|---|---|---|---|---|---|---|---|
| Canon Medical System, USA, Inc. | 510(k) number | 2025-12-19 | Class II | Under Investigation by firm | There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pres | 22 systems | |
| Canon Medical System, USA, Inc. | 510(k) number | 2024-05-10 | Class II | Device Design | The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smo | 153 | |
| Canon Medical System, USA, Inc. | 510(k) number | 2021-05-21 | Class II | Under Investigation by firm | The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire. | ||
| Toshiba American Medical Systems Inc | 510(k) number | 2016-04-14 | Class II | Device Design | A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System. | 33 units | 2017-03-30 |
| Toshiba American Medical Systems Inc | 510(k) number | 2012-10-15 | Class II | Nonconforming Material/Component | It was found that there is a problem with the LCD monitor used in the console. The LCD monitor may become blank during use. Specifically, the backlight of the LCD monitor may turn off while the system is in use, causing the LCD monitor to b | 27 units | 2013-11-06 |
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.