510(k) · Cleared
ClearedAiris, Airis 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 Oct 8, 1999 as substantially equivalent to K980691 (Hitachi Medical Systems America, Inc., 1998) and 1 other predicate after a 63-day review. Its family tree reaches back 2 generations to 1998. 7 later devices descend from it.
- Decided
- Oct 8, 1999
- Review
- 63 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K974212 (1998). 3 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK974212 Airis IIHitachi Medical Systems America, Inc. · 1998 · Recalled
- 1 generation backK984278 Magnetic Resonance Diagnostic Device, Airis IIHitachi Medical Systems America, Inc. · 1998
- This deviceK992650 Airis, Airis IIHitachi Medical Systems America, Inc. · 1999
- Descendant · cites it directly · 5 of its ownK013854 Mark 5000 Quadrature Shoulder CoilUsa Instruments, Inc. · 2002
- Descendant · 2 generations on · 4 of its ownK033753 Pelvic Array CoilUsa Instruments, Inc. · 2003
- Descendant · 3 generations on · 2 of its ownK061715 Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc. · 2006
- Descendant · 4 generations on · 1 of its ownK083434 TT1 General Purpose CoilTursiop Technologies, LLC · 2008
- Descendant · 5 generations on · 0 of its ownK113280 Carotid Coil GE 1.5TTursiop Technologies, LLC · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K013854Mark 5000 Quadrature Shoulder CoilUsa Instruments, Inc. · 2002 · cites it directly5descendants
- K033753Pelvic Array CoilUsa Instruments, Inc. · 2003 · 2 generations on4descendants
- K061715Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc. · 2006 · 3 generations on2descendants
- K083434TT1 General Purpose CoilTursiop Technologies, LLC · 2008 · 4 generations on1descendant
- K113280Carotid Coil GE 1.5TTursiop Technologies, LLC · 2011 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974212 | Airis II | Hitachi Medical Systems America, Inc. | 1998 | 5 |
| −1 | K984278 | Magnetic Resonance Diagnostic Device, Airis II | Hitachi Medical Systems America, Inc. | 1998 | — |
| 0 (this device) | K992650 | Airis, Airis II | Hitachi Medical Systems America, Inc. | 1999 | — |
| +1 | K013854 | Mark 5000 Quadrature Shoulder Coil | Usa Instruments, Inc. | 2002 | — |
| +2 | K033753 | Pelvic Array Coil | Usa Instruments, Inc. | 2003 | — |
| +3 | K061715 | Mrgfus General Purpose and Breast Coil | Insightec Txsonics, Inc. | 2006 | — |
| +4 | K083434 | TT1 General Purpose Coil | Tursiop Technologies, LLC | 2008 | — |
| +5 | K113280 | Carotid Coil GE 1.5T | Tursiop Technologies, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K980691 | Airis Magnetic Resonance Diagnostic DeviceSummary page 2…Resonance Specialty Coil) Trade/Proprietary Name: AIRIS, AIRIS II PREDICATE DEVICE(s): Hitachi AIRIS, AIRIS 11 DEVICE DESCRIPTION: FUNCTION Identical to the AIRIS 510(k) K980691. Identical to the AIRIS II 510(k) K984278. The AIRISand AIRIS II MRI Magnetic Resonance Diagnostic Devices are being enhanced by… | 1998 |
| * | K984278 | Magnetic Resonance Diagnostic Device, Airis IISummary page 2…y Name: AIRIS, AIRIS II PREDICATE DEVICE(s): Hitachi AIRIS, AIRIS 11 DEVICE DESCRIPTION: FUNCTION Identical to the AIRIS 510(k) K980691. Identical to the AIRIS II 510(k) K984278. The AIRISand AIRIS II MRI Magnetic Resonance Diagnostic Devices are being enhanced by one additional RF Coil (PA/QD Shoulder Co… | 1998 |
What descends from it? (7)
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?
- The line of descent spans 1 year and passes through 1 company; a new generation was cleared every 10 months on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K013854 (Usa Instruments, Inc., 2002) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K980691.
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 PA/QD Shoulder Coil provides imaging of the shoulder articular anatomy and other large joints. 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.…
Read the full statement (265 words)
The PA/QD Shoulder Coil provides imaging of the shoulder articular anatomy and other large joints.
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 (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/K992650 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992650: Airis, 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/K992650
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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