510(k) K133692 ยท LNH System, Nuclear Magnetic Resonance Imaging
IMRI 1.5T AND IMRI 3T S
| Applicant | Imris, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Feb 10, 2014 |
| Received | Dec 2, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133692
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2025 | IMPRIS Imaging Inc IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla
MRI Magnet, Verio Open, Classified |
LNH | None listed |
| Oct 28, 2025 | IMPRIS Imaging Inc IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra Open, Classified |
LNH | None listed |
| Oct 28, 2025 | IMPRIS Imaging Inc IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA Open, Classified |
LNH | None listed |
| Oct 28, 2025 | IMPRIS Imaging Inc IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida Open, Classified |
LNH | None listed |
| Apr 4, 2018 | Deerfield Imaging, Inc. IMRIS IMRI 1.5T AND 3T S System
Product Usage:
The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative ins Terminated |
LNH | None listed |
| Mar 11, 2016 | Deerfield Imaging Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S.
Indicated for use as a magnetic resonance diagnostic device (MRDD). Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.