510(k) · Cleared
ClearedAiris II Magnetic Resonance Diagnostic Device,Interventional MR Package
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 8, 1999 as substantially equivalent to K974212 (Hitachi Medical Systems America, Inc., 1998) and 2 other predicates after a 70-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Feb 8, 1999
- Review
- 70 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K955389 (1996). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK955389 MR Guided Procedures Package/Magnetom Open SystemSiemens Medical Solutions USA, Inc. · 1996
- This deviceK984280 Airis II Magnetic Resonance Diagnostic Device,Interventional MR…Hitachi Medical Systems America, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK053309 Altaire Interventional MR PackageHitachi Medical Systems America, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K053309Altaire Interventional MR PackageHitachi Medical Systems America, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955389 | MR Guided Procedures Package/Magnetom Open System | Siemens Medical Solutions USA, Inc. | 1996 | — |
| 0 (this device) | K984280 | Airis II Magnetic Resonance Diagnostic Device,Interventional MR Package | Hitachi Medical Systems America, Inc. | 1999 | — |
| +1 | K053309 | Altaire Interventional MR Package | Hitachi Medical Systems America, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 2…lear Magnetic Resonance Imaging Product Code(s): 90LNH 90MOS (Magnetic Resonance Specialty Coil) Trade/Proprietary Name: AIRISII PREDICATE DEVICE(s): Hitachi AIRIS II (K974212) Siemens Magnetom OPEN (K955389) Siemens Magnetom VISION and IMPACT (K962927) DEVICE DESCRIPTION: FUNCTION Identical to the AIRI… | 1998 |
| * | K955389 | MR Guided Procedures Package/Magnetom Open SystemSummary page 2…Product Code(s): 90LNH 90MOS (Magnetic Resonance Specialty Coil) Trade/Proprietary Name: AIRISII PREDICATE DEVICE(s): Hitachi AIRIS II (K974212) Siemens Magnetom OPEN (K955389) Siemens Magnetom VISION and IMPACT (K962927) DEVICE DESCRIPTION: FUNCTION Identical to the AIRIS II 510(k) K974212. The AIRIS… | 1996 |
| * | K962927 | IN-Room MRC/ Magnetom Vision and Impact SystemsSummary page 2…ance Specialty Coil) Trade/Proprietary Name: AIRISII PREDICATE DEVICE(s): Hitachi AIRIS II (K974212) Siemens Magnetom OPEN (K955389) Siemens Magnetom VISION and IMPACT (K962927) DEVICE DESCRIPTION: FUNCTION Identical to the AIRIS II 510(k) K974212. The AIRIS II MRI Magnetic Resonance Diagnostic Device i… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053309 | Altaire Interventional MR Package | 2006 | 0 |
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?
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?
By providing in-suite scan control and viewing of MR images, the AIRIS II with the Interventional MR Package aids in the performance of minimally invasive, diagnostic, and therapeutic procedures of the head, body and extremities which may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation, as selected and evaluated by the clinical user. The MR system is an imaging device, and is intended to…
Read the full statement (336 words)
By providing in-suite scan control and viewing of MR images, the AIRIS II with the Interventional MR Package aids in the performance of minimally invasive, diagnostic, and therapeutic procedures of the head, body and extremities which may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation, as selected and evaluated by the clinical user.
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 Spin Echo (SE); also with rephase
2D Gradient Field Eche (GE); also with rephase (2D GR)
2D Steady state acquisition with rewinded GE (SARGE); also with RF spoiling, rephasing
2D Inversion Recovery (IR)
2D Fast Spin Echo (FSE); also with rephase
2D Fast Inversion Recovery (FIR)
2D Dual Slice acquisition (SEDS)
3D Spin Echo (SE)
3D Gradient Field Echo (GE)
3D Steady state acquisition with rewinded GE (SARGE); also with RF spoiling, rephasing
MR Angiography (2D TOF, 3D TOF, half echo, high resolution/high definition, sloped slab profile, magnetization transfer contrast)
MR Fluoroscapy
RF Coil Uniformity
Adaptive Image post-processing
ACR/NEMA/DICOM 3 compliant
Aids in the performance of minimally invasive, diagnostic, and therapeutic procedures of the head, body and extremities which may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation, as selected and evaluated by the clinical user.
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/K984280 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984280: Airis II Magnetic Resonance Diagnostic Device,Interventional MR Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984280
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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