# K994378: Airis II

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Mar 7, 2000 after 71 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: 1 generation back to K974212 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The AIRIS II Magnetic Resonance Diagnostic Device with the CTL Phased Array Coil P/N MR-CTL-51 provides for continuous imaging of the cervical, thoracic, and lumbar spine and adjacent anatomies. 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: Nucleus excited: Diagnostic uses: Imaging capabilities: Head, Body, Spine, Extremities Proton 2D T1-/T2-weighted imaging T1, T2, proton density measurements MR Angiography image processing 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/K994378
Methodology: https://510kreport.com/methodology