# K974498: Stratis II

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Feb 26, 1998 after 90 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.
No later device cites it as a predicate yet.
0 of 1 device 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: named in the summary without a submission number
- (no number) Hitachi STRATIS with Version 6-05 Operating System Software: named in the summary without a submission number

## 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, 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 2D, 3D TOF 2D, 3D TOF RSSG ECG, Peripheral Gating Fat Suppression

Source page: https://510kreport.com/device/K974498
Methodology: https://510kreport.com/methodology