# K961969: Hitachi Stratis, MRH-1500 Magnetic Resonance Diagnostic Devices Version 6 Operating System Software

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Sep 5, 1996 after 108 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
No predicates in its family tree.
8 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) Hitachi STRATIS with Version 3 Operating System Software: named in the summary without a submission number
- (no number) Hitachi MRH-1500 with Version 3 Operating System Software: named in the summary without a submission number

## Most influential descendants
- K043271: R2-Mri Analysis System (2005), 7 descendants of its own
- K122035: Hepafat Scan (2013), 3 descendants of its own
- K201039: HepaFat-AI (2020), 2 descendants of its own
- K213960: LiverMultiScan v5 (LMSv5) (2022), 1 descendant of its own
- K253413: LiverMultiScan (v6.0) (2026), 0 descendants of its own

## 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 Imaging capabilities: 2D, 3D Spin Echo (SE) 2D Short Spin Echo (SES) 2D, 3D Fast Spin Echo (FSE) 2D Inversion Recovery (IR) 2D, 3D Fast Inversion Recovery (FIR) 2D,3D Gradient Field Echo (GFE); also with rephasing 2D, 3D Rapid Scan (RS) MTC, RF Spoiling MR Angiography, (2D INFA, 3D INFA, 2D GFEA, 3D GFEA, Sloped Slab Profile (SSP)) RF Coil Uniformity Adaptive Image post-processing

Source page: https://510kreport.com/device/K961969
Methodology: https://510kreport.com/methodology