510(k) · Cleared
ClearedI_Open 0.4T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Wandong Medical Equipment Co., Ltd. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Mar 25, 2009 as substantially equivalent to K974212 (Hitachi Medical Systems America, Inc., 1998) and 1 other predicate after a 34-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Mar 25, 2009
- Review
- 34 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. No later device cites it as a predicate yet.
- Root · 1 generation backK974212 Airis IIHitachi Medical Systems America, Inc. · 1998 · Recalled
- This deviceK090433 I_Open 0.4TBeijing Wandong Medical Equipment Co., Ltd. · 2009
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) | K090433 | I_Open 0.4T | Beijing Wandong Medical Equipment 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? (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 |
|---|---|---|---|
| * | K974212 | Airis IISummary page 2…on Windows®XP is an interactive program integrated with scanning control, image reconstruction, reviewing, post-processing, DICOM printing. * Predicated Device: K974212: Hitachi AIRIS II K001334: AIRIS II Version 4.1 Software 0 Statement of Substantial Equivalence: The i/Op… | 1998 |
| * | K001334 | Hitachi Airis IISummary page 2…program integrated with scanning control, image reconstruction, reviewing, post-processing, DICOM printing. * Predicated Device: K974212: Hitachi AIRIS II K001334: AIRIS II Version 4.1 Software 0 Statement of Substantial Equivalence: The i/Open OAT is of comparable type an… | 2000 |
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?
- 2 of the 2 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 i Open O.4T 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 iOpen O.4T system reflect the special distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density…
Read the full statement (169 words)
The i Open O.4T 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 iOpen O.4T system reflect the special 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 determining a diagnosis.
* Anatomical Region: Head, Body, Spine, Extremities
* Nucleus excited: Proton
- Diagnostic uses:
Ti, T2 weighted
Proton density weighted
MIP-MRA
Water suppress imaging
fat suppress imaging
MRCP
* Imaging capabilities:
2D Spin Echo (SE)
2D,3D Fast Spin Echo(FSE)
2D Short Tau Inversion-Recovery (STIR)
2D Fluid Attenuated Inversion Recovery (FLAIR)
2D,3D Rewinded Gradient Echo (2D, 3D Rewinded-GRE)
2D, 3D Spoiled Gradient Echo (2D,3D Spoiled-GRE)
2D,3D Time of Flight Angiography (TOF)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090433 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090433: I_Open 0.4T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090433
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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