# K984280: Airis II Magnetic Resonance Diagnostic Device,Interventional MR Package

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Feb 8, 1999 after 70 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- 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: 1 generation back to K955389 (1996). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974212: Airis II, Hitachi Medical Systems America, Inc. (1998) Summary page 2.
- K955389: MR Guided Procedures Package/Magnetom Open System, Siemens Medical Solutions USA, Inc. (1996) Summary page 2.
- K962927: IN-Room MRC/ Magnetom Vision and Impact Systems, Siemens Medical Solutions USA, Inc. (1996) Summary page 2.

## Most influential descendants
- K053309: Altaire Interventional MR Package (2006), 0 descendants of its own

## Indications for use
By providing in-suite scan control and viewing of MR images, the AIRIS II with the Interventional MR Package 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. 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 Eche (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 Fluoroscapy 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/K984280
Methodology: https://510kreport.com/methodology