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Vantage Elan 1.5T, V4.0

by Toshibamedical Systems Corporation

510(k) K171597

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK171597 Date21 Jul 2017ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0199-2019 FDA Class II initiated 30 May 2018

    When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specific Absorption Rate) value displayed on the console may be lower than the actual SAR value. The actual applied SAR values may exceed the FIRST LEVEL CONTROLLED OPERATING MODE.

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  • Withdrawn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, 24 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 Vantage Elan 1.5T, V4.0 is a System, Nuclear Magnetic Resonance Imaging device. It utilizes nuclear magnetic resonance properties of protons to generate cross-sectional images of head and body anatomy.

It is manufactured by Toshibamedical Systems Corporation and received FDA 510(k) clearance under K171597 on July 21, 2017. The device is classified as Class II with product code LNH and regulation number 892.1000, and is subject to special controls.

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Questions

AI-generated answers, 24 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 Vantage Elan 1.5T, V4.0 used for?

    The Vantage Elan 1.5T, V4.0 is a System, Nuclear Magnetic Resonance Imaging device that utilizes the nuclear magnetic resonance properties of protons to generate cross-sectional images of head and body anatomy, enabling detailed internal visualization for diagnostic purposes.

  • Who manufactures the Vantage Elan 1.5T, V4.0 and when was it cleared?

    The Vantage Elan 1.5T, V4.0 is manufactured by Toshibamedical Systems Corporation and received FDA 510(k) clearance under submission K171597 on July 21, 2017, following a traditional review process that determined it to be substantially equivalent to a predicate device.

  • What regulatory classification and controls apply to the Vantage Elan 1.5T, V4.0?

    The Vantage Elan 1.5T, V4.0 is classified as a Class II medical device with product code LNH and regulation number 892.1000, and is subject to special controls as required by the FDA for devices in this category to ensure safety and effectiveness.