# K032232: Airis Elite Magnetic Resonance Imaging Device

- Pathway: 510(k) (Abbreviated)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Sep 29, 2003 after 70 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974212 (1998). 2 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001334: Hitachi Airis II, Hitachi Medical Systems America, Inc. (2000)
- K974212: Airis II, Hitachi Medical Systems America, Inc. (1998) Summary page 2.

## Most influential descendants
- K233629: APERTO Lucent MRI System (2024), 2 descendants of its own
- K253862: APERTO Lucent MRI System (2026), 1 descendant of its own
- K241133: Magnifico Open (100009900); Magnifico MSK ( 100009910) (2024), 1 descendant of its own
- K261283: APERTO Lucent MRI System (2026), 0 descendants of its own
- K251901: Magnifico Open (100009900) (2026), 0 descendants of its own

## Recalls of this device
- 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.
- Jun 30, 2005 · Not classified · Z-0890-05: Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.

## Indications for use
The AIRIS Elite system is an MR 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, obliq,ue, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the 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 (TI), 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,’3D T1, T2-weighted imaging T1, T2 proton density measurements Diffusion weighted imaging MF, Angiography Image processing

Source page: https://510kreport.com/device/K032232
Methodology: https://510kreport.com/methodology