510(k) · Cleared
ClearedSuperopen 0.23T, Model Nam-P023A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neusoft Digital Medical Systems Co., Ltd. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Oct 29, 2003 as substantially equivalent to K030918 (Neusoft Digital Medical Systems Co., Ltd., 2003) after a 14-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it.
- Decided
- Oct 29, 2003
- Review
- 14 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. 2 later devices descend from it, 1 citing it directly.
- 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 deviceK033315 Superopen 0.23T, Model Nam-P023ANeusoft Digital Medical Systems Co., Ltd. · 2003
- Descendant · cites it directly · 1 of its ownK062860 Modification to Superopen 0.23T, Model Nam-P023ANeusoft Medical Systems Co., Ltd. · 2006
- Descendant · 2 generations on · 0 of its ownK082485 Modification to Superopen 0.23T Mri System, Model Nam-P023ANeusoft Medical Systems Co., Ltd. · 2008
Most influential descendants
Showing 2 of 2 · See allView 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) | K033315 | Superopen 0.23T, Model Nam-P023A | Neusoft Digital Medical Systems Co., Ltd. | 2003 | — |
| +1 | K062860 | Modification to Superopen 0.23T, Model Nam-P023A | Neusoft Medical Systems Co., Ltd. | 2006 | — |
| +2 | K082485 | Modification to Superopen 0.23T Mri System, Model Nam-P023A | Neusoft Medical Systems Co., Ltd. | 2008 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 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….35T (MRI System) Statement of Substantial Equivalence: The Superopen 0.23T is of comparable type and substantially equivalent to the NEUSOFT Superopen 0.35T (K030918) in that they are similar in technology and intended uses. Both of these systems are open-permanent-magnet MR Imaging System,… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062860 | Modification to Superopen 0.23T, Model Nam-P023A | 2006 | 1 |
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 5 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K062860 (Neusoft Medical Systems Co., Ltd., 2006) has gone furthest, with 1 descendant of its own.
- 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 0.23T 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 h4RI system reflect the spatial distribution of protons (hydrogen…
Read the full statement (195 words)
The Superopen 0.23T 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 h4RI 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 (T l), 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
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033315: Superopen 0.23T, Model Nam-P023A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033315
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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