# K113145: Echelon Oval Mri System

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: May 1, 2012 after 189 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K955249 (1995). 8 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083533: Echelon C Mri System, Hitachi Medical Systems America, Inc. (2009) Summary page 1.

## Most influential descendants
- K151015: ECHELON Oval V 5.0 MRI System (2015), 6 descendants of its own
- K153547: ECHELON Oval V 5.1 MRI System (2016), 5 descendants of its own
- K172110: ECHELON OVAL V6.0A MRI System (2018), 4 descendants of its own
- K223426: ECHELON Synergy MRI system (2023), 3 descendants of its own
- K233687: ECHELON Synergy V10.0 (2024), 2 descendants of its own

## Recalls of this device
- Apr 16, 2015 · Class II · Z-1541-2017: Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
- Aug 18, 2014 · Class II · Z-2564-2014: The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
- Jan 31, 2013 · Class II · Z-1559-2013: Hitachi discovered a software error that can occur when simultaneously scanning a patient while processing images previously acquired from a different patient. The software error can occur randomly. T

## Indications for use
The ECHELON Oval MRI 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 (TI), 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: TI, T2, proton density weighted imaging Diffusion weighted imaging MR Angiography Image processing Spectroscopy Whole Body

Source page: https://510kreport.com/device/K113145
Methodology: https://510kreport.com/methodology