510(k) · Cleared
ClearedModification to Superopen 0.23T Mri System, Model Nam-P023A
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 Sep 9, 2008 as substantially equivalent to K062860 (Neusoft Medical Systems Co., Ltd., 2006) and 1 other predicate after a 12-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Sep 9, 2008
- Review
- 12 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K931544 (1993). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK931544 1.5T Edge and 1.0T Vista SystemsPhilips Medical Systems (Cleveland), Inc. · 1993 · Recalled
- 6 generations backK954646 Epi-II System Option W/High Performance GradientsPhilips Medical Systems (Cleveland), Inc. · 1996
- 5 generations backK964626 Edge/Vista System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1997 · Recalled
- 4 generations backK974844 Outlook System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1998
- 3 generations backK013858 Infinion 0.6T MR Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2002 · Recalled
- 2 generations backK024042 Panorama EnhancementsPhilips Medical Systems, Inc. · 2003
- 1 generation backK071154 Superstar 0.35T Mri SystemNeusoft Medical Systems Co., Ltd. · 2007
- This deviceK082485 Modification to Superopen 0.23T Mri System, Model Nam-P023ANeusoft Medical Systems Co., Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931544 | 1.5T Edge and 1.0T Vista Systems | Philips Medical Systems (Cleveland), Inc. | 1993 | 2 |
| −6 | K954646 | Epi-II System Option W/High Performance Gradients | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −5 | K964626 | Edge/Vista System Enhancement Package | Philips Medical Systems (Cleveland), Inc. | 1997 | 4 |
| −4 | K974844 | Outlook System Enhancement Package | Philips Medical Systems (Cleveland), Inc. | 1998 | — |
| −3 | K013858 | Infinion 0.6T MR Imaging System | Philips Medical Systems (Cleveland), Inc. | 2002 | 2 |
| −2 | K024042 | Panorama Enhancements | Philips Medical Systems, Inc. | 2003 | — |
| −1 | K071154 | Superstar 0.35T Mri System | Neusoft Medical Systems Co., Ltd. | 2007 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 2 | 0 |
| 2006 | 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? (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 | Decided |
|---|---|---|---|
| * | K062860 | Modification to Superopen 0.23T, Model Nam-P023ASummary page 2…The Superopen 0.23T (modified) system used the same materials, construction and operating principle as our existing marketed product, Superopen 0.23T MRM system (K062860) and Superstar 0.35T(K071154) Predicated Device: K062860: Superopen 0.23T K071154: Superstar 0.35T Statement of… | 2006 |
| * | K071154 | Superstar 0.35T Mri SystemSummary page 2…system used the same materials, construction and operating principle as our existing marketed product, Superopen 0.23T MRM system (K062860) and Superstar 0.35T(K071154) Predicated Device: K062860: Superopen 0.23T K071154: Superstar 0.35T Statement of Substantial Equivalence: The… | 2007 |
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 15 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 15 ancestors have a recall of any class.
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. 2008, this device’s year, is highlighted.
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 MRL system reflect the spatial distribution of protons (hydrogen nuclei)…
Read the full statement (203 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 MRL 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, Neck, Shoulder, Breast, Wrist, Ankle, Body, Spine, Knee, 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)
Turbo spin echo (TSE)
Short time inversion recovery (STIR); Fast STIR, IRFFE,
IRSE, Fast IR, IR TSE
Fluid attenuated inversion recovery (FLAIR); Fast FLAIR
2D,3D Fast Field Echo (FFE)
Tl/T2/N-Fast field echo (FFE);
N-Fast filed echo 3D; TI-Fast field echo 3D;
Dual echo (DE);DTSE; DSE;
MR angiography FE, FFE 3D;
Echo Planar Imaging (EPI)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082485 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082485: Modification to Superopen 0.23T Mri System, Model Nam-P023A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082485
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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