510(k) · Cleared

Recalled · Class II · 2016

Neuro II-SE, Models or-MB-DR and or-DR

K061916510(k) TraditionalCleared Aug 11, 200636-day reviewClass II21 CFR 892.1000Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Imris, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Aug 11, 2006 after a 36-day review. The FDA summary names its predicate without a number. 2 later devices descend from it. It has been recalled 2 times.

Decided: Aug 11, 2006
Review: 36 days
Class: Class II
Product code: LNH
Recalls: 2
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK061916 Neuro II-SE, Models or-MB-DR and or-DRImris, Inc. · 2006
Descendant · cites it directly · 1 of its ownK091166 IMRXImris, Inc. · 2009
Descendant · cites it directly · 0 of its ownK103506 1.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc. · 2011

Most influential descendants

Showing 2 of 2 · See all

K091166IMRXImris, Inc. · 2009 · cites it directly1descendant
K1035061.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc. · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K061916	Neuro II-SE, Models or-MB-DR and or-DR	Imris, Inc.	2006	—
+1	K091166	IMRX	Imris, Inc.	2009	—
+1	K103506	1.5T Head Coil (HC150), 3T Head Coil (HC300)	Imris, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2011	1	0

FIG. 1 — Lineage of K061916, 2006–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Planning a device in LNH? 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

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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	Recalls
*	—	Neuro II-S Named without a submission number	—
*	—	Neuro II Named without a submission number	—
*	—	Siemens Magnetom Espree Named without a submission number	—

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K091166	IMRX	Imris, Inc.	2009	1
K103506	1.5T Head Coil (HC150), 3T Head Coil (HC300)	Imris, Inc.	2011	0

Has anything in its family been recalled? (0 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…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K091166 (Imris, Inc., 2009) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNH

26in 2025

2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007high 140 (2015) · low 35 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LNH

8in 2025

2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007high 1,263 (2025) · low 84 (2021)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 II-SE MRI system is indicated for use for the head and whole body. The Neuro Il-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 (T1) and spin-spin relaxation time (12); and 3. display the soft…

Read the full statement (133 words)

The IMRIS Neuro II-SE MRI system is indicated for use for the head and whole body.

The Neuro Il-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 (T1) and spin-spin relaxation time (12); 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 II-SE may also be used in a multi-room suite.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061916 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061916: Neuro II-SE, Models or-MB-DR and or-DR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061916

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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