510(k) · Cleared
Recalled · 2006Airis Elite Magnetic Resonance Imaging Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Medical Systems America, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Sep 29, 2003 as substantially equivalent to K001334 (Hitachi Medical Systems America, Inc., 2000) and 1 other predicate after a 70-day review. Its family tree reaches back 1 generation to 1998. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 29, 2003
- Review
- 70 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K974212 (1998). 2 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK974212 Airis IIHitachi Medical Systems America, Inc. · 1998 · Recalled
- This deviceK032232 Airis Elite Magnetic Resonance Imaging DeviceHitachi Medical Systems America, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK233629 APERTO Lucent MRI SystemFUJIFILM Healthcare Americas Corporation · 2024
- Descendant · 2 generations on · 1 of its ownK253862 APERTO Lucent MRI SystemFujifilm Corporation · 2026
- Descendant · cites it directly · 1 of its ownK241133 Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A. · 2024
- Descendant · 3 generations on · 0 of its ownK261283 APERTO Lucent MRI SystemFujifilm Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK251901 Magnifico Open (100009900)Esaote, S.p.A. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K233629APERTO Lucent MRI SystemFUJIFILM Healthcare Americas Corporation · 2024 · cites it directly2descendants
- K253862APERTO Lucent MRI SystemFujifilm Corporation · 2026 · 2 generations on1descendant
- K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A. · 2024 · cites it directly1descendant
- K261283APERTO Lucent MRI SystemFujifilm Corporation · 2026 · 3 generations on0descendants
- K251901Magnifico Open (100009900)Esaote, S.p.A. · 2026 · 2 generations on0descendants
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) | K032232 | Airis Elite Magnetic Resonance Imaging Device | Hitachi Medical Systems America, Inc. | 2003 | — |
| +1 | K233629 | APERTO Lucent MRI System | FUJIFILM Healthcare Americas Corporation | 2024 | — |
| +2 | K253862 | APERTO Lucent MRI System | Fujifilm Corporation | 2026 | — |
| +1 | K241133 | Magnifico Open (100009900); Magnifico MSK ( 100009910) | Esaote, S.p.A. | 2024 | — |
| +3 | K261283 | APERTO Lucent MRI System | Fujifilm Corporation | 2026 | — |
| +2 | K251901 | Magnifico Open (100009900) | Esaote, S.p.A. | 2026 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K001334 | Hitachi Airis II | 2000 |
| * | K974212 | Airis IISummary page 2…ification Number: 90LNH Trade/Proprietary Name: AIRIS Elite Predicate Device(s): AIRIS I1 (KO01334, K9742 12) 3.0 Device Intended Use The MR system is an imaging device and is intended to provide the physician with physiologi… | 1998 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 21, 2006 | Not classified | Z-0910-06 | Other | The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures. |
| Jun 30, 2005 | Not classified | Z-0890-05 | Other | Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 AIRIS Elite system is an MR 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 MR system produces transverse, coronal, sagittal, obliq,ue, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the system reflect the spatial distribution of protons (hydrogen…
Read the full statement (135 words)
The AIRIS Elite system is an MR 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 MR system produces transverse, coronal, sagittal, obliq,ue, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the 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.
Anatomical Region: Head, Body, Spine, Extremities
Nucleus excited: Proton
Diagnostic uses: 2D,’3D T1, T2-weighted imaging
T1, T2 proton density measurements
Diffusion weighted imaging
MF, Angiography
Image processing
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032232: Airis Elite Magnetic Resonance Imaging Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032232
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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