# K172110: ECHELON OVAL V6.0A MRI System

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Healthcare Americas Corporation
- Decided: Jan 11, 2018 after 182 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K955249 (1995). 11 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153547: ECHELON Oval V 5.1 MRI System, Hitachi Medical Systems America, Inc. (2016) Summary page 5.

## Most influential descendants
- K223426: ECHELON Synergy MRI system (2023), 3 descendants of its own
- K233687: ECHELON Synergy V10.0 (2024), 2 descendants of its own
- K241429: ECHELON Synergy MRI System (2024), 1 descendant of its own
- K251386: ECHELON Synergy (2025), 0 descendants of its own

## Recalls of this device
- Jul 29, 2021 · Class II · Z-2338-2021: There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.

## 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 (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: T1, T2, proton density weighted imaging Diffusion weighted imaging MR Angiography Image processing Spectroscopy Whole Body

Source page: https://510kreport.com/device/K172110
Methodology: https://510kreport.com/methodology