510(k) · Cleared
Recalled · 2006Airis II
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 Feb 9, 1998 after a 91-day review. The FDA summary names its predicate without a number. 32 later devices descend from it. It has been recalled 5 times.
- Decided
- Feb 9, 1998
- Review
- 91 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 5
- Predicates
- 0
32 later devices descend from it, 10 citing it directly.
- This deviceK974212 Airis IIHitachi Medical Systems America, Inc. · 1998
- Descendant · cites it directly · 8 of its ownK030918 Superopen 0.35T, Model NSM-P035Neusoft Digital Medical Systems Co., Ltd. · 2003
- Descendant · cites it directly · 8 of its ownK984278 Magnetic Resonance Diagnostic Device, Airis IIHitachi Medical Systems America, Inc. · 1998
- Descendant · 2 generations on · 7 of its ownK992650 Airis, Airis IIHitachi Medical Systems America, Inc. · 1999
- Descendant · cites it directly · 6 of its ownK032232 Airis Elite Magnetic Resonance Imaging DeviceHitachi Medical Systems America, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 5 of its ownK013854 Mark 5000 Quadrature Shoulder CoilUsa Instruments, Inc. · 2002
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K030918Superopen 0.35T, Model NSM-P035Neusoft Digital Medical Systems Co., Ltd. · 2003 · cites it directly8descendants
- K984278Magnetic Resonance Diagnostic Device, Airis IIHitachi Medical Systems America, Inc. · 1998 · cites it directly8descendants
- K992650Airis, Airis IIHitachi Medical Systems America, Inc. · 1999 · 2 generations on7descendants
- K032232Airis Elite Magnetic Resonance Imaging DeviceHitachi Medical Systems America, Inc. · 2003 · cites it directly6descendants
- K013854Mark 5000 Quadrature Shoulder CoilUsa Instruments, Inc. · 2002 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974212 | Airis II | Hitachi Medical Systems America, Inc. | 1998 | — |
| +1 | K030918 | Superopen 0.35T, Model NSM-P035 | Neusoft Digital Medical Systems Co., Ltd. | 2003 | — |
| +1 | K984278 | Magnetic Resonance Diagnostic Device, Airis II | Hitachi Medical Systems America, Inc. | 1998 | — |
| +2 | K992650 | Airis, Airis II | Hitachi Medical Systems America, Inc. | 1999 | — |
| +1 | K032232 | Airis Elite Magnetic Resonance Imaging Device | Hitachi Medical Systems America, Inc. | 2003 | 2 |
| +3 | K013854 | Mark 5000 Quadrature Shoulder Coil | Usa Instruments, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 5 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | — | Hitachi AIRIS Named without a submission number | |
| * | — | Hitachi AIRIS with Version 4.0 Operating System Software Named without a submission number |
What descends from it? (32)
See all 3210 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030918 | Superopen 0.35T, Model NSM-P035 | 2003 | 8 |
| K984278 | Magnetic Resonance Diagnostic Device, Airis II | 1998 | 8 |
| K032232 | Airis Elite Magnetic Resonance Imaging Device | 2003 | 6 |
| K984280 | Airis II Magnetic Resonance Diagnostic Device,Interventional MR Package | 1999 | 1 |
| K092899 | Oper Series Open Type Permanent-Magnet Mri System, Model: Oper-0.3, -0.35, -0.4 | 2009 | 0 |
| K090873 | I Open 0.5T | 2009 | 0 |
| K090433 | I_Open 0.4T | 2009 | 0 |
| K090080 | Cirrus Open | 2009 | 0 |
| K994378 | Airis II | 2000 | 0 |
| K990153 | Virgo Mri System | 1999 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 28, 2006 | Not classified | Z-1104-06 | Other | Software anomaly-A software defect can cause the slice line indicator to become mis-positioned during Multi-Planar Reconstructions (MPR) with the potential for patient mis-diagnosis. |
| Apr 25, 2006 | Not classified | Z-1115-06 | Other | Improper Assembly-The AIRIS/AIRIS II MRI system has the potential for the input wiring of a power transformer to overheat due to damaged wiring or possible loose connections. |
| 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. |
| Dec 1, 2005 | Not classified | Z-0429-06 | Other | The bolts holding the lift mechanism may be damaged causing them to fail and the table top to drop several inches. |
| Jun 30, 2005 | Not classified | Z-0889-05 | 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?
- Of its descendants, K030918 (Neusoft Digital Medical Systems Co., Ltd., 2003) has gone furthest, with 8 descendants of its own.
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 MR system 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 MR 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 the MR system reflect the spatial distribution of protons (hydrogen nuclei)…
Read the full statement (188 words)
The MR system 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 MR 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 the MR 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 (T1), 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 T1-/T2-weighted imaging
T1, T2, proton density measurements
MR Angiography
image processing
Imaging capabilities:
2D, 3D Spin Echo (SE)
2D, 3D Fast Spin Echo (FSE)
2D Inversion Recovery (IR)
2D, 3D Fast Inversion Recovery (FIR)
2D,3D Gradient Echo (GE)
2D, 3D Steady state acquisition with rewinded GE (SARGE)
2D, 3D RF-spoiled SARGE (RSSG)
2D, 3D Time-reversed SARGE (TRSG)
MR Angiography
2D, 3D TOF
2D, 3D TOF RSSG
ECG, Peripheral Gating
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974212 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974212: Airis II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974212
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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