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Echelon Oval MRI System

by Hitachi Medical Systems America, Inc.

510(k) K113145

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK113145 Date1 May 2012ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1541-2017 FDA Class II initiated 16 Apr 2015

    Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.

    • Terminated Z-2564-2014 FDA Class II initiated 18 Aug 2014

    The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.

    • Terminated Z-1559-2013 FDA Class II initiated 31 Jan 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. The error causes an image in the processed dataset to have the same unique identifier (UID) as in the scanning dataset. The processed image is stored in the place of the original image, which is lost.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Echelon Oval MRI System is a nuclear magnetic resonance imaging system. It is designed to produce diagnostic images of the human body.

This device is regulated under FDA 510(k) clearance. It is a 1.5T MRI system featuring a 74cm oval bore.

Other devices from Hitachi Medical Systems America, Inc.

See all devices from Hitachi Medical Systems America, Inc. →

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Echelon Oval MRI System?

    The Echelon Oval MRI System is a nuclear magnetic resonance imaging device designed to produce diagnostic images of the human body.

  • What are the key physical specifications of this MRI system?

    This device is a 1.5T MRI system that features a 74cm oval bore, which is designed to accommodate patient imaging needs.

  • What is the regulatory status of the Echelon Oval MRI System?

    The Echelon Oval MRI System is regulated under FDA 510(k) clearance, having been determined to be substantially equivalent to other devices in its class.