# K974212: Airis II

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Feb 9, 1998 after 91 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
32 later devices descend from it; 10 cite it directly.
0 of 33 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
- (no number) Hitachi AIRIS with Version 4.0 Operating System Software: named in the summary without a submission number

## Most influential descendants
- K030918: Superopen 0.35T, Model NSM-P035 (2003), 8 descendants of its own
- K984278: Magnetic Resonance Diagnostic Device, Airis II (1998), 8 descendants of its own
- K992650: Airis, Airis II (1999), 7 descendants of its own
- K032232: Airis Elite Magnetic Resonance Imaging Device (2003), 6 descendants of its own
- K013854: Mark 5000 Quadrature Shoulder Coil (2002), 5 descendants of its own

## Recalls of this device
- Apr 28, 2006 · Not classified · Z-1104-06: Software anomaly-A software defect can cause the slice line indicator to become mis-positioned during Multi-Planar Reconstructions (MPR) with the potential for patient mis-diagnosis.
- Apr 25, 2006 · Not classified · Z-1115-06: Improper Assembly-The AIRIS/AIRIS II MRI system has the potential for the input wiring of a power transformer to overheat due to damaged wiring or possible loose connections.
- Feb 21, 2006 · Not classified · Z-0910-06: The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures.
- Dec 1, 2005 · Not classified · Z-0429-06: The bolts holding the lift mechanism may be damaged causing them to fail and the table top to drop several inches.
- Jun 30, 2005 · Not classified · Z-0889-05: Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.

## 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, 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 2D, 3D TOF 2D, 3D TOF RSSG ECG, Peripheral Gating

Source page: https://510kreport.com/device/K974212
Methodology: https://510kreport.com/methodology