Skip to content

ECHELON Oval V 5.0 MRI System

by Hitachi Medical Systems America, Inc.

510(k) K151015

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK151015 Date29 Jul 2015ClearedStatusActive

Recalls

1 recall · 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.

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  • Withdrawn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, 21 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 V 5.0 MRI System is a System, Nuclear Magnetic Resonance Imaging device classified under medical specialty Radiology. It is a substantially equivalent device cleared via the traditional 510(k) pathway under regulation number 892.1000.

The device was manufactured by Hitachi Medical Systems America, Inc., located at 1959 Summit Commerce Park, Twinsburg, OH 44087. It received FDA 510(k) clearance under K151015 on July 29, 2015, following submission on April 16, 2015.

Other devices from Hitachi Medical Systems America, Inc.

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

Questions

AI-generated answers, 21 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 ECHELON Oval V 5.0 MRI System used for?

    The ECHELON Oval V 5.0 MRI System is a nuclear magnetic resonance imaging device intended for use in radiology to produce detailed images of internal body structures for diagnostic purposes, as indicated by its medical specialty classification and clearance under regulation 892.1000.

  • How was the ECHELON Oval V 5.0 MRI System cleared for market?

    The device received FDA 510(k) clearance through the traditional pathway under K151015, determined to be substantially equivalent to a predicate device, based on the submission received April 16, 2015, and cleared on July 29, 2015.

  • Who manufactures the ECHELON Oval V 5.0 MRI System and where is it located?

    The ECHELON Oval V 5.0 MRI System is manufactured by Hitachi Medical Systems America, Inc., located at 1959 Summit Commerce Park, Twinsburg, OH 44087, United States, as specified in the device registration and authorization details.