# K980691: Airis Magnetic Resonance Diagnostic Device

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: May 11, 1998 after 77 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
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Hitachi AIRIS: named in the summary without a submission number

## Most influential descendants
- K992650: Airis, Airis II (1999), 7 descendants of its own
- 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

## Indications for use
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

Source page: https://510kreport.com/device/K980691
Methodology: https://510kreport.com/methodology