510(k) K212367 ยท LNH System, Nuclear Magnetic Resonance Imaging
IMRIS iMRI 3T V
| Applicant | Deerfield Imaging, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Aug 23, 2021 |
| Received | Jul 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212367
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.