# K992650: Airis, Airis II

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Oct 8, 1999 after 63 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K974212 (1998). 3 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980691: Airis Magnetic Resonance Diagnostic Device, Hitachi Medical Systems America, Inc. (1998) Summary page 2.
- K984278: Magnetic Resonance Diagnostic Device, Airis II, Hitachi Medical Systems America, Inc. (1998) Summary page 2.

## Most influential descendants
- K013854: Mark 5000 Quadrature Shoulder Coil (2002), 5 descendants of its own
- K033753: Pelvic Array Coil (2003), 4 descendants of its own
- K061715: Mrgfus General Purpose and Breast Coil (2006), 2 descendants of its own
- K083434: TT1 General Purpose Coil (2008), 1 descendant of its own
- K113280: Carotid Coil GE 1.5T (2011), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K992650
Methodology: https://510kreport.com/methodology