# K984274: Magnetic Resonance Diagnostic Device, Version 5.0 Operating System Software

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Jan 25, 1999 after 56 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 K971279 (1997). 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)
- K971279: Version 4 Operating System Software, Hitachi Medical Systems America, Inc. (1997) Summary page 2.

## 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 Inversion Recovery (IR) 2D, 3D Fast Spin Echo (FSE), Fast Inversion Recovery (FIR) 2D,3D Gradient Field Echo (GE); also with rephasing (GR) 2D Steady state acquisition with rewinded GE (SARGE) 3D Steady state acquisition with rewinded GE (SARGE); also with rephasing 2D Dual Slice acquisition (DS) MR Angiography (2D TOF, 3D TOF, half echo, high resolution/high definition, sloped slab profile, on- and off-resoance magnetization transfer contrast) RF Coil Uniformity Adaptive Image post-processing

Source page: https://510kreport.com/device/K984274
Methodology: https://510kreport.com/methodology