510(k) · Cleared
ClearedAiris Magnetic Resonance Diagnostic Device
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 May 11, 1998 after a 77-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- May 11, 1998
- Review
- 77 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK980691 Airis Magnetic Resonance Diagnostic DeviceHitachi Medical Systems America, Inc. · 1998
- Descendant · cites it directly · 7 of its ownK992650 Airis, Airis IIHitachi Medical Systems America, Inc. · 1999
- Descendant · 2 generations on · 5 of its ownK013854 Mark 5000 Quadrature Shoulder CoilUsa Instruments, Inc. · 2002
- Descendant · 3 generations on · 4 of its ownK033753 Pelvic Array CoilUsa Instruments, Inc. · 2003
- Descendant · 4 generations on · 2 of its ownK061715 Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc. · 2006
- Descendant · 5 generations on · 1 of its ownK083434 TT1 General Purpose CoilTursiop Technologies, LLC · 2008
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K992650Airis, Airis IIHitachi Medical Systems America, Inc. · 1999 · cites it directly7descendants
- K013854Mark 5000 Quadrature Shoulder CoilUsa Instruments, Inc. · 2002 · 2 generations on5descendants
- K033753Pelvic Array CoilUsa Instruments, Inc. · 2003 · 3 generations on4descendants
- K061715Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc. · 2006 · 4 generations on2descendants
- K083434TT1 General Purpose CoilTursiop Technologies, LLC · 2008 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980691 | Airis Magnetic Resonance Diagnostic Device | Hitachi Medical Systems America, Inc. | 1998 | — |
| +1 | K992650 | Airis, Airis II | Hitachi Medical Systems America, Inc. | 1999 | — |
| +2 | K013854 | Mark 5000 Quadrature Shoulder Coil | Usa Instruments, Inc. | 2002 | — |
| +3 | K033753 | Pelvic Array Coil | Usa Instruments, Inc. | 2003 | — |
| +4 | K061715 | Mrgfus General Purpose and Breast Coil | Insightec Txsonics, Inc. | 2006 | — |
| +5 | K083434 | TT1 General Purpose Coil | Tursiop Technologies, LLC | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 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 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 |
|---|---|---|---|
| * | — | Hitachi AIRIS Named without a submission number |
What descends from it? (9)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K992650 (Hitachi Medical Systems America, Inc., 1999) has gone furthest, with 7 descendants of its own.
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 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 (235 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 Spin Echo (SE); also with rephase
2D Gradient Field Echo (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 Fluoroscopy
RF Coil Uniformity
Adaptive Image post-processing
ACR/NEMA/DICOM 3 compliant
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/K980691 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980691: Airis Magnetic Resonance Diagnostic Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980691
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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