510(k) · Cleared
Recalled · Class I · 2025Imri 1.5T and Imri 3T S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imris, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Feb 10, 2014 as substantially equivalent to K071099 (Imris, Inc., 2007) and 1 other predicate after a 70-day review. Its family tree reaches back 1 generation to 2007. 3 of the 6 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 6 times, including 4 Class I recalls.
- Decided
- Feb 10, 2014
- Review
- 70 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 6 (4 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K071099 (2007). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly. 3 of the 6 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK071099 Neuro II-SE, Models: or-DR-or, or-MBImris, Inc. · 2007 · Recalled
- This deviceK133692 Imri 1.5T and Imri 3T SImris, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK212367 IMRIS iMRI 3T VDeerfield Imaging, Inc. · 2021 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK252239 InVision™ 3T Recharge Operating SuiteImris Imaging, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK240157 InVision™ 1.5 Surgical TheatreDeerfield Imaging, Inc. · 2024
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071099 | Neuro II-SE, Models: or-DR-or, or-MB | Imris, Inc. | 2007 | 2 |
| 0 (this device) | K133692 | Imri 1.5T and Imri 3T S | Imris, Inc. | 2014 | — |
| +1 | K212367 | IMRIS iMRI 3T V | Deerfield Imaging, Inc. | 2021 | Class I |
| +2 | K252239 | InVision™ 3T Recharge Operating Suite | Imris Imaging, Inc. | 2025 | — |
| +2 | 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 |
|---|---|---|
| 2021 | 1 | 1 |
| 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? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071099 | Neuro II-SE, Models: or-DR-or, or-MBSummary page 2…Il-SE MRI system. Siemens AGNETOM Aera is a reference device. 51(k Deiso Dat De.c Nam Manfacure K071099 May 22, 2007 Neuro 1l-SE Intra-operative Magnetic IMRIS Inc. ____… | 2007 |
| * | K083137 | Neuro Iii-SVSummary page 2…ll-SV MRI system. Siemens MAGNETOM Skyra is a reference device. I 51(k Deiso Da. Deic Nam Maufctre K083137 Dec 16, 2008 Neuro lll-SV Intra-operative Magnetic IMRIS Inc. ____… | 2008 |
| † | K101347 | Magnetom Aera; Magnetom Skyra | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212367 | IMRIS iMRI 3T V Class I | 2021 | 2 |
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… |
| Apr 4, 2018 | Class II | Z-1645-2018 | Device Design | The DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the magnetic field. Our investigation shows the magnetic field is causing the IFOSS control panel to malfunction. |
| Feb 10, 2016 | Class II | Z-1098-2016 | Device Design | Emergency helium venting lines (i.e. quench lines) may not have been properly installed. |
The 5 latest of 6 recalls; the web page lists all.
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?
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. 2014, 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 iMRI 1.5T A and 3T S are 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…
Read the full statement (156 words)
The iMRI 1.5T A and 3T S are 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 iMRI 1.5T A and 3T S systems 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 iMRI 1ST A and 3T S 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/K133692 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133692: Imri 1.5T and Imri 3T S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133692
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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