510(k) · Cleared
ClearedAiris II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Medical Systems America, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Mar 7, 2000 as substantially equivalent to K974212 (Hitachi Medical Systems America, Inc., 1998) after a 71-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Mar 7, 2000
- Review
- 71 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974212 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK974212 Airis IIHitachi Medical Systems America, Inc. · 1998 · Recalled
- This deviceK994378 Airis IIHitachi Medical Systems America, Inc. · 2000
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) | K994378 | Airis II | Hitachi Medical Systems America, Inc. | 2000 | — |
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 MOS? 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 MOS device
- #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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…(Magnetic Resonance Specialty Coil) Trade/Proprietary Name: AIRIS II PREDICATE DEVICE(s): Hitachi AIRIS 1I DEVICE DESCRIPTION: FUNCTION Identical to the AIRIS II 510(k) K974212. The AIRIS IT MRI Magnetic Resonance Diagnostic Device is being enhanced by one additional RF Coil (CTL Phased Array Coil) to in… | 1998 |
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?
- Its one ancestor has a recall.
- 9 other devices also cite its predicate K974212.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 2025
MAUDE reports naming product code MOS, 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 | 16 | 19 | 0 | 4 |
| 2008 | 19 | 33 | 2 | 2 |
| 2009 | 10 | 43 | 0 | 5 |
| 2010 | 16 | 78 | 1 | 13 |
| 2011 | 25 | 57 | 0 | 7 |
| 2012 | 15 | 49 | 1 | 12 |
| 2013 | 7 | 87 | 0 | 10 |
| 2014 | 12 | 60 | 0 | 4 |
| 2015 | 6 | 58 | 2 | 5 |
| 2016 | 11 | 42 | 0 | 7 |
| 2017 | 9 | 63 | 0 | 9 |
| 2018 | 10 | 30 | 0 | 7 |
| 2019 | 3 | 178 | 8 | 8 |
| 2020 | 5 | 51 | 1 | 2 |
| 2021 | 4 | 41 | 0 | 3 |
| 2022 | 11 | 79 | 0 | 5 |
| 2023 | 10 | 59 | 0 | 4 |
| 2024 | 10 | 39 | 13 | 8 |
| 2025 | 3 | 59 | 0 | 2 |
| 2026 | 10 | 45 | 0 | — |
What is it indicated for?
The AIRIS II Magnetic Resonance Diagnostic Device with the CTL Phased Array Coil P/N MR-CTL-51 provides for continuous imaging of the cervical, thoracic, and lumbar spine and adjacent anatomies. 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…
Read the full statement (278 words)
The AIRIS II Magnetic Resonance Diagnostic Device with the CTL Phased Array Coil P/N MR-CTL-51 provides for continuous imaging of the cervical, thoracic, and lumbar spine and adjacent anatomies.
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:
Nucleus excited:
Diagnostic uses:
Imaging capabilities:
Head, Body, Spine, Extremities
Proton
2D T1-/T2-weighted imaging
T1, T2, proton density measurements
MR Angiography
image processing
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 (half echo, high resolution/high definition, sloped
slab profile, magnetization transfer contrast)
2D, 3D TOF
2D, 3D TOF RSSG
ECG, Peripheral Gating
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/K994378 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994378: 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/K994378
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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