510(k) · Cleared
ClearedOper Series Open Type Permanent-Magnet Mri System, Model: Oper-0.3, -0.35, -0.4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ningbo Xingaoyi Magnetism Co., Ltd. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Nov 10, 2009 as substantially equivalent to K974212 (Hitachi Medical Systems America, Inc., 1998) and 2 other predicates after a 50-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Nov 10, 2009
- Review
- 50 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 3
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 deviceK092899 Oper Series Open Type Permanent-Magnet Mri System, Model: Oper-0.3…Ningbo Xingaoyi Magnetism Co., Ltd. · 2009
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) | 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 |
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? (3)
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 |
|---|---|---|---|
| * | K974212 | Airis IISummary page 3…n time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. 3.5 Predicated Devices K974212: Hitachi AIRIS II, manufactured by Hitachi Medical Systems America, Inc. K001334: AIRIS II Version 4.1 Software, manufa… | 1998 |
| * | K001334 | Hitachi Airis IISummary page 3…ormation that can be useful in determining a diagnosis. 3.5 Predicated Devices K974212: Hitachi AIRIS II, manufactured by Hitachi Medical Systems America, Inc. K001334: AIRIS II Version 4.1 Software, manufactured by Hitachi Medical Systems America, Inc. K030918: Superopen 0.35T, Model N… | 2000 |
| * | K030918 | Superopen 0.35T, Model NSM-P035Summary page 3…chi AIRIS II, manufactured by Hitachi Medical Systems America, Inc. K001334: AIRIS II Version 4.1 Software, manufactured by Hitachi Medical Systems America, Inc. K030918: Superopen 0.35T, Model NSM-P035 MRI System, manufactured by Neusoft Digital Medical Systems Co., Ltd. === Pag… | 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 11 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 9 other devices also cite its predicate K974212.
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. 2009, 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 OPER Series Open Type Permanent-Magnet MRI System is an open, whole body scanner. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the head, body, or extremities. The images produced by the OPER Series Open Type Permanent-Magnet MRI System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR…
Read the full statement (106 words)
The OPER Series Open Type Permanent-Magnet MRI System is an open, whole body scanner. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the head, body, or extremities. The images produced by the OPER Series Open Type Permanent-Magnet 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 (T11), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092899 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092899: Oper Series Open Type Permanent-Magnet Mri System, Model: Oper-0.3, -0.35, -0.4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092899
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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