510(k) Report

510(k) · Cleared

Cleared

Airis II Magnetic Resonance Diagnostic Device,Interventional MR Package

K984280510(k) TraditionalCleared Feb 8, 199970-day reviewClass II21 CFR 892.1000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1996: 1 other ancestor2006: 1 descendant clearedK955389 · MR Guided Procedures Package/Magnetom Open System · Siemens Medical Solutions USA, Inc. · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K955389 · MR Guided Procedures Package/Magnetom Open System · Siemens Medical Solutions USA, Inc. · 19960
  1. Root · 1 generation backK955389 MR Guided Procedures Package/Magnetom Open SystemSiemens Medical Solutions USA, Inc. · 1996
  2. This deviceK984280 Airis II Magnetic Resonance Diagnostic Device,Interventional MR…Hitachi Medical Systems America, Inc. · 1999
  3. 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

GenerationNumberDeviceApplicantDecidedRecalls
−1K955389MR Guided Procedures Package/Magnetom Open SystemSiemens Medical Solutions USA, Inc.1996—
0 (this device)K984280Airis II Magnetic Resonance Diagnostic Device,Interventional MR PackageHitachi Medical Systems America, Inc.1999—
+1K053309Altaire Interventional MR PackageHitachi Medical Systems America, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K984280, 1996–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K974212Airis II
Summary 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…
Hitachi Medical Systems America, Inc.19985
*K955389MR Guided Procedures Package/Magnetom Open System
Summary 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…
Siemens Medical Solutions USA, Inc.1996—
*K962927IN-Room MRC/ Magnetom Vision and Impact Systems
Summary 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…
Siemens Medical Solutions USA, Inc.1996—

Also cleared against K974212: 9 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K053309Altaire Interventional MR PackageHitachi Medical Systems America, Inc.20060

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?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K053309 (Hitachi Medical Systems America, Inc., 2006) has gone furthest, with 0 descendants of its own.
  • 9 other devices also cite its predicate K974212.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNH

26in 2025

2007: 122008: 192009: 172010: 122011: 162012: 222013: 192014: 172015: 192016: 202017: 182018: 292019: 262020: 322021: 272022: 302023: 302024: 262025: 262026 (partial year): 24
2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007: 35 days median2008: 53 days median2009: 70 days median2010: 94 days median2011: 81 days median2012: 89 days median2013: 108 days median2014: 108 days median2015: 140 days median2016: 108 days median2017: 98 days median2018: 128 days median2019: 62 days median2020: 121 days median2021: 87 days median2022: 74 days median2023: 124 days median2024: 104 days median2025: 122 days median2026 (partial year): 126 days median
2007high 140 (2015) · low 35 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LNH

8in 2025

2007: 252008: 122009: 72010: 172011: 112012: 52013: 22014: 132015: 12, 2 Class I2016: 12018: 712019: 52020: 42021: 412022: 132023: 10, 1 Class I2024: 42025: 8, 5 Class I2026 (partial year): 43
2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007: 1142008: 1672009: 1942010: 1652011: 1822012: 1702013: 1072014: 1192015: 1132016: 1352017: 1212018: 1582019: 1582020: 982021: 842022: 1382023: 1592024: 2812025: 1,263
2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007123525114
2008195312167
200917707194
2010129417165
2011168111182
201222895170
2013191082107
20141710813119
20151914012 (2)113
2016201081135
201718980121
20182912871158
201926625158
202032121498
202127874184
2022307413138
20233012410 (1)159
2024261044281
2025261228 (5)1,263
20262412643—

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.

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