510(k) · Cleared

Cleared

Superopen 0.35T, Model NSM-P035

K030918510(k) TraditionalCleared Apr 1, 20038-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

Neusoft Digital Medical Systems Co., Ltd. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Apr 1, 2003 as substantially equivalent to K974212 (Hitachi Medical Systems America, Inc., 1998) and 1 other predicate after an 8-day review. Its family tree reaches back 1 generation to 1998. 8 later devices descend from it.

Decided: Apr 1, 2003
Review: 8 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K974212 (1998). 2 ancestors in all. 8 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK974212 Airis IIHitachi Medical Systems America, Inc. · 1998 · Recalled
This deviceK030918 Superopen 0.35T, Model NSM-P035Neusoft Digital Medical Systems Co., Ltd. · 2003
Descendant · cites it directly · 3 of its ownK071154 Superstar 0.35T Mri SystemNeusoft Medical Systems Co., Ltd. · 2007
Descendant · cites it directly · 2 of its ownK033315 Superopen 0.23T, Model Nam-P023ANeusoft Digital Medical Systems Co., Ltd. · 2003
Descendant · 2 generations on · 1 of its ownK062860 Modification to Superopen 0.23T, Model Nam-P023ANeusoft Medical Systems Co., Ltd. · 2006
Descendant · 2 generations on · 0 of its ownK131737 Supernova C5 Mri SystemLiaoning Kampo Medical System Co., Ltd. · 2014
Descendant · cites it directly · 0 of its ownK092899 Oper Series Open Type Permanent-Magnet Mri System, Model: Oper-0.3…Ningbo Xingaoyi Magnetism Co., Ltd. · 2009

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2003high 2 (2006) · low 0 (2004)2026

Most influential descendants

Showing 5 of 8 · See all

K071154Superstar 0.35T Mri SystemNeusoft Medical Systems Co., Ltd. · 2007 · cites it directly3descendants
K033315Superopen 0.23T, Model Nam-P023ANeusoft Digital Medical Systems Co., Ltd. · 2003 · cites it directly2descendants
K062860Modification to Superopen 0.23T, Model Nam-P023ANeusoft Medical Systems Co., Ltd. · 2006 · 2 generations on1descendant
K131737Supernova C5 Mri SystemLiaoning Kampo Medical System Co., Ltd. · 2014 · 2 generations on0descendants
K092899Oper Series Open Type Permanent-Magnet Mri System, Model: Oper-0.3, -0.35, -0.4Ningbo Xingaoyi Magnetism Co., Ltd. · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K974212	Airis II	Hitachi Medical Systems America, Inc.	1998	5
0 (this device)	K030918	Superopen 0.35T, Model NSM-P035	Neusoft Digital Medical Systems Co., Ltd.	2003	—
+1	K071154	Superstar 0.35T Mri System	Neusoft Medical Systems Co., Ltd.	2007	—
+1	K033315	Superopen 0.23T, Model Nam-P023A	Neusoft Digital Medical Systems Co., Ltd.	2003	—
+2	K062860	Modification to Superopen 0.23T, Model Nam-P023A	Neusoft Medical Systems Co., Ltd.	2006	—
+2	K131737	Supernova C5 Mri System	Liaoning Kampo Medical System Co., Ltd.	2014	—
+1	K092899	Oper Series Open Type Permanent-Magnet Mri System, Model: Oper-0.3, -0.35, -0.4	Ningbo Xingaoyi Magnetism Co., Ltd.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2006	2	0
2007	1	0
2008	1	0
2009	2	0
2014	1	0

FIG. 1 — Lineage of K030918, 1998–2014Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K974212	Airis II Summary page 2 …with user-friendly interface. Its functions cover scanning conti-01, image reconstruction and imageiarchive management and maintenance. Predicated Device: K9742 12 : AIRIS I1 (MRI System) K001334: AIRIS I1 Version 4.1 Software Statement of Substaiitial Equivalence: Tlie Superopen 0…	Hitachi Medical Systems America, Inc.	1998	5
*	K001334	Hitachi Airis II Summary page 2 …functions cover scanning conti-01, image reconstruction and imageiarchive management and maintenance. Predicated Device: K9742 12 : AIRIS I1 (MRI System) K001334: AIRIS I1 Version 4.1 Software Statement of Substaiitial Equivalence: Tlie Superopen 0.35T is of comparable type and subst…	Hitachi Medical Systems America, Inc.	2000	3

Also cleared against K974212: 9 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K071154	Superstar 0.35T Mri System	Neusoft Medical Systems Co., Ltd.	2007	3
K033315	Superopen 0.23T, Model Nam-P023A	Neusoft Digital Medical Systems Co., Ltd.	2003	2
K092899	Oper Series Open Type Permanent-Magnet Mri System, Model: Oper-0.3, -0.35, -0.4	Ningbo Xingaoyi Magnetism Co., Ltd.	2009	0
K061132	Modification to Superopen 0.35T, Model NSM-P035	Neusoft Medical Systems Co., Ltd.	2006	0

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?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K071154 (Neusoft Medical Systems Co., Ltd., 2007) has gone furthest, with 3 descendants of its own.
9 other devices also cite its predicate K974212.

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?

Read the full statement (206 words)

The Superopen 0.35T is an imaging device, and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the use of ionizing radiation. The MRI system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by MRI system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The IWR properties that determine the image appearance are proton density, spin-lattice relaxation time (Tl), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be usehl in diagnosis determination.

The indications for use are as follows:

Anatomical Region: Head, Body, Spine, Extremities

Nucleus excited: Proton

Diagnostic uses: T1 ,T2, proton density weighted imaging

Diffusion weighted imaging

MR Angiography

Imaging processing

Imaging capabilities: 2D, 3D Spin Echo( SE )

Short time inversion recovery (STIR)

Fluid attenuated inversion recovery (FLAJR)

2D,3D Field Echo (FE)

2D, 3D Field Echo with Spoiler (FESP)

2D FESP Multi-Slice (FESP-MS)

2D and 3D Field Echo Steady State FID with rephasing gradient (FESS-FID)

2D, 3D Fast Spin Echo (FSE)

2D, 3D MRCP

MR Angiography

2D, 3D TOF

MTC

Echo Planar Imaging (EPI)

Multi-shot SE / FE

Diffusion

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030918 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030918: Superopen 0.35T, Model NSM-P035.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030918

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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