510(k) · Cleared
Recalled · Class I · 2025IMRIS iMRI 3T V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deerfield Imaging, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Aug 23, 2021 as substantially equivalent to K133692 (Imris, Inc., 2014) after a 24-day review. Its family tree reaches back 2 generations to 2007. 3 of the 6 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 4 times, including 4 Class I recalls.
- Decided
- Aug 23, 2021
- Review
- 24 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 4 (4 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K071099 (2007). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly. 3 of the 6 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK071099 Neuro II-SE, Models: or-DR-or, or-MBImris, Inc. · 2007 · Recalled
- 1 generation backK133692 Imri 1.5T and Imri 3T SImris, Inc. · 2014 · Recalled (Class I)
- This deviceK212367 IMRIS iMRI 3T VDeerfield Imaging, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK252239 InVision™ 3T Recharge Operating SuiteImris Imaging, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK240157 InVision™ 1.5 Surgical TheatreDeerfield Imaging, Inc. · 2024
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K071099 | Neuro II-SE, Models: or-DR-or, or-MB | Imris, Inc. | 2007 | 2 |
| −1 | K133692 | Imri 1.5T and Imri 3T S | Imris, Inc. | 2014 | Class I |
| 0 (this device) | K212367 | IMRIS iMRI 3T V | Deerfield Imaging, Inc. | 2021 | — |
| +1 | K252239 | InVision™ 3T Recharge Operating Suite | Imris Imaging, Inc. | 2025 | — |
| +1 | K240157 | InVision™ 1.5 Surgical Theatre | Deerfield Imaging, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 30, 2025 | Class I | Z-0162-2026 | Under Investigation by firm | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the… |
| Sep 30, 2025 | Class I | Z-0161-2026 | Under Investigation by firm | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the… |
| Sep 30, 2025 | Class I | Z-0163-2026 | Under Investigation by firm | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the… |
| Sep 30, 2025 | Class I | Z-0164-2026 | Under Investigation by firm | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 7.5 years on median.
- 3 of the 3 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K252239 (Imris Imaging, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
The IMRIS iMRI 3T V is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These…
Read the full statement (146 words)
The IMRIS iMRI 3T V is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body or extremities.
Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The IMRIS iMRI 3T V system may also be used for imaging during intra-operative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner.
The IMRIS iMRI 3T V MRI systems may also be used for imaging in a multi-room suite.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212367: IMRIS iMRI 3T V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212367
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026