The following data is part of a premarket notification filed by Imig-mri Systems, Llc. with the FDA for Imig-mri.
| Device ID | K963953 |
| 510k Number | K963953 |
| Device Name: | IMIG-MRI |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | IMIG-MRI SYSTEMS, LLC. 300 VESPER EXECUTIVE PARK Tyngsborough, MA 01879 |
| Contact | Gregory C Hurst |
| Correspondent | Gregory C Hurst IMIG-MRI SYSTEMS, LLC. 300 VESPER EXECUTIVE PARK Tyngsborough, MA 01879 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-02 |
| Decision Date | 1996-12-18 |
| Summary: | summary |