# K083533: Echelon C Mri System

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Feb 17, 2009 after 81 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K955249 (1995). 7 ancestors in all.
11 later devices descend from it; 1 cites 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)
- K052172: HHF1 Magnetic Resonance Imaging System, Hitachi Medical Systems America, Inc. (2005) Summary page 1.

## Most influential descendants
- K113145: Echelon Oval Mri System (2012), 10 descendants of its own
- 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

## Recalls of this device
- Jul 29, 2021 · Class II · Z-2337-2021: 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.
- Apr 16, 2015 · Class II · Z-1542-2017: Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.

## Indications for use
The ECHELON C 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.

Source page: https://510kreport.com/device/K083533
Methodology: https://510kreport.com/methodology