510(k) · Cleared

Cleared

Neuro II-S

K050132510(k) TraditionalCleared Feb 15, 200525-day reviewClass II21 CFR 892.1000

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

Innovative Magnetic Resonance Imaging Systems, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Feb 15, 2005 as substantially equivalent to K002964 (Innovative Magnetic Resonance Imaging Systems, Inc., 2000) and 2 other predicates after a 25-day review. Its family tree reaches back 3 generations to 1993.

Decided: Feb 15, 2005
Review: 25 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K931544 (1993). 12 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK931544 1.5T Edge and 1.0T Vista SystemsPhilips Medical Systems (Cleveland), Inc. · 1993 · Recalled
2 generations backK954646 Epi-II System Option W/High Performance GradientsPhilips Medical Systems (Cleveland), Inc. · 1996
1 generation backK964626 Edge/Vista System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1997 · Recalled
This deviceK050132 Neuro II-SInnovative Magnetic Resonance Imaging Systems, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K931544	1.5T Edge and 1.0T Vista Systems	Philips Medical Systems (Cleveland), Inc.	1993	2
−2	K954646	Epi-II System Option W/High Performance Gradients	Philips Medical Systems (Cleveland), Inc.	1996	—
−1	K964626	Edge/Vista System Enhancement Package	Philips Medical Systems (Cleveland), Inc.	1997	4
0 (this device)	K050132	Neuro II-S	Innovative Magnetic Resonance Imaging Systems, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1997	2	0
1999	1	0
2000	3	0
2001	1	0
2002	1	0

FIG. 1 — Lineage of K050132, 1993–2005Source: 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? (4)

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	Applicant	Decided	Recalls
*	K002964	Neuro II Summary page 2 …Device Manufactured by FDA Classification * 510(k) # Neuro IITM 1.5T MRI Innovative Magnetic 892.1000 K002964 system Resonance Imaging Systems, Inc. (IMRIS) Magnetom Symphony…	Innovative Magnetic Resonance Imaging Systems, Inc.	2000	—
*	K020991	Syngo MR 2002B Summary page 2 …Resonance Imaging Systems, Inc. (IMRIS) Magnetom Symphony Siemens Medical Solutions 892.1000 K020991 System USA, Inc. Edge Eclipse 1.5T T M Picker International Inc. 892.1000 K964…	Siemens Medical Solutions USA, Inc.	2002	2
*	K964626	Edge/Vista System Enhancement Package Summary page 2 …lutions 892.1000 K020991 System USA, Inc. Edge Eclipse 1.5T T M Picker International Inc. 892.1000 K964626 Magnet, NMR (Marconi Medical Systems) Electronics & VIA 2.0 Software ©IMRIS…	Philips Medical Systems (Cleveland), Inc.	1997	4
*	—	Picker Large Joint Coil Named without a submission number			—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
8 of the 12 ancestors have a recall of any class.

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 11-S MRI system is indicated for use for the whole body. The Neuro 1I-S 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…

Read the full statement (120 words)

The IMRIS Neuro 11-S MRI system is indicated for use for the whole body.

The Neuro 1I-S 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 11-S 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050132 · printed Nov 4, 2026

Cite this page

510(k) Report. “K050132: Neuro II-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050132

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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