510(k) · Cleared
ClearedModification to Superopen 0.35T, Model NSM-P035
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neusoft Medical Systems Co., Ltd. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on May 24, 2006 as substantially equivalent to K030918 (Neusoft Digital Medical Systems Co., Ltd., 2003) after a 30-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- May 24, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K974212 (1998). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK974212 Airis IIHitachi Medical Systems America, Inc. · 1998 · Recalled
- 1 generation backK030918 Superopen 0.35T, Model NSM-P035Neusoft Digital Medical Systems Co., Ltd. · 2003
- This deviceK061132 Modification to Superopen 0.35T, Model NSM-P035Neusoft Medical Systems Co., Ltd. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974212 | Airis II | Hitachi Medical Systems America, Inc. | 1998 | 5 |
| −1 | K030918 | Superopen 0.35T, Model NSM-P035 | Neusoft Digital Medical Systems Co., Ltd. | 2003 | — |
| 0 (this device) | K061132 | Modification to Superopen 0.35T, Model NSM-P035 | Neusoft Medical Systems Co., Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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.
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
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K030918 | Superopen 0.35T, Model NSM-P035Summary page 2…ogram with user-friendly interface. Its functions cover scanning control, image reconstruction and image/archive management and maintenance. Predicated Device: K030918 : Superopen 0.35T Statement of Substantial Equivalence: The Superopen 0.35T(Modified) is of comparable type and substantiall… | 2003 |
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 8 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 3 other devices also cite its predicate K030918.
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.
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 Superopen 0.35T(Modified) 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…
Read the full statement (204 words)
The Superopen 0.35T(Modified) 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 NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
The indications for use are as follows:
Anatomical Region: Head, Body, Spine, Extremities
Nucleus excited: Proton
Diagnostic uses: TI,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 (FLAIR)
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/K061132 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061132: Modification to Superopen 0.35T, Model NSM-P035.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061132
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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