FDA Information
MRI Device and FDA Information for IRB Applications/Renewals
The IRB requires applications/renewals list information on the device to be used, including FDA numbers and device descriptions. Below is the information users should include with their applications:
| Machine Nickname | Device Type | Device Trade Name | FDA 510(K) Number | Manufacturer / Supplier | CFR & Product Label for Device |
| Modular Unit MRI Machine | 3T MRI Scanner | GE MR750 3.0T With Discovery MR System | K081028 | General Electric | Product Label CFR Listing |
| BIRB MRI Machine | 3T MRI Scanner | GE MR750 3.0T With Discovery MR System | K081028 | General Electric | Product Label CFR Listing |
TMS Device and FDA Information for IRB Applications/Renewals
The IRB requires applications/renewals list information on the device to be used, including FDA numbers and device descriptions. Below is the information users should include with their applications:
| Device Trade Name | FDA 510(K) Number | Manufacturer / Supplier | CFR & Product Label for Device |
| Magstim Double 70mm Air Film Coil Model | K080499 | The Magstim Company Ltd. | Product Label CFR Listing |
| Magstim 200-2 | K060847 | Magstim Company Us, Llc. | Product Label CFR Listing |