510(k) · Cleared
Recalled · Class II · 2016Neuro II-SE, Models: or-DR-or, or-MB
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 May 22, 2007 after a 33-day review. The FDA summary names its predicate without a number. 2 of the 9 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- May 22, 2007
- Review
- 33 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 2
- Predicates
- 0
8 later devices descend from it, 4 citing it directly. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- This deviceK071099 Neuro II-SE, Models: or-DR-or, or-MBImris, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK133692 Imri 1.5T and Imri 3T SImris, Inc. · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK212367 IMRIS iMRI 3T VDeerfield Imaging, Inc. · 2021 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK110411 Atama SystemMonteris Medical, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK091166 IMRXImris, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK252239 InVision™ 3T Recharge Operating SuiteImris Imaging, Inc. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K133692Imri 1.5T and Imri 3T SImris, Inc. · 2014 · cites it directly3descendants
- K212367IMRIS iMRI 3T VDeerfield Imaging, Inc. · 2021 · 2 generations on2descendants
- K110411Atama SystemMonteris Medical, Inc. · 2011 · cites it directly1descendant
- K091166IMRXImris, Inc. · 2009 · cites it directly1descendant
- K252239InVision™ 3T Recharge Operating SuiteImris Imaging, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071099 | Neuro II-SE, Models: or-DR-or, or-MB | Imris, Inc. | 2007 | — |
| +1 | K133692 | Imri 1.5T and Imri 3T S | Imris, Inc. | 2014 | Class I |
| +2 | K212367 | IMRIS iMRI 3T V | Deerfield Imaging, Inc. | 2021 | Class I |
| +1 | K110411 | Atama System | Monteris Medical, Inc. | 2011 | — |
| +1 | K091166 | IMRX | Imris, Inc. | 2009 | — |
| +3 | K252239 | InVision™ 3T Recharge Operating Suite | Imris Imaging, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 2 | 1 |
| 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.
2 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? (3)
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 |
|---|---|---|---|
| * | — | Neuro II-SE Named without a submission number | |
| * | — | Neuro II-S Named without a submission number | |
| * | — | Siemens Magnetom Espree Named without a submission number |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 10, 2016 | Class II | Z-1098-2016 | Device Design | Emergency helium venting lines (i.e. quench lines) may not have been properly installed. |
| Oct 19, 2012 | Class II | Z-0428-2013 | Labeling design | IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This… |
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?
- Of its descendants, K133692 (Imris, Inc., 2014) has gone furthest, with 3 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. 2007, 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 Neuro I1-SE MRI system is indicated for use for the head and whole body. The Neuro 1I-SE is intended for use as a diagnostic patient imaging device. This device produces tomographic cross-sectional images that: 1. correspond to the distribution of protons exhibiting MR characteristics; 2. depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time (Ti) and spin-spin relaxation time (T2); and 3. display the soft…
Read the full statement (133 words)
The IMRIS Neuro I1-SE MRI system is indicated for use for the head and whole body.
The Neuro 1I-SE is intended for use as a diagnostic patient imaging device. This device produces tomographic cross-sectional images that:
1. correspond to the distribution of protons exhibiting MR characteristics;
2. depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time (Ti) and spin-spin relaxation time (T2); and
3. display the soft tissue structure of the body.
When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The Neuro I-SE may also be used during intra-operative procedures when performed in an intra-operative MRI suite with MR compatible devices such as anesthesia and patient monitoring equipment.
The Neuro 1I-SE may also be used in a multi-room suite.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071099 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071099: Neuro II-SE, Models: or-DR-or, or-MB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071099
Report an extraction error
Are you the manufacturer?
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