510(k) K101813 ยท LNH System, Nuclear Magnetic Resonance Imaging
IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO
| Applicant | Imris, Inc., Rockville MD, US |
| Decision | Substantially Equivalent, Oct 5, 2010 |
| Received | Jun 29, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101813
| 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 |
| Nov 26, 2019 | Deerfield Imaging, Inc. iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography.
The IMRIS iMRX system is the integration of a Siemens A Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.