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Vectra Magnetic Resonance System

by General Electric Co. 2 variants

510(k) K913673

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 NumberK913673 Date23 Jan 1992ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0618-2022 FDA Class II initiated 23 Dec 2021

    The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

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  • Withdrawn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, 1 Oct 2026

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

The Vectra Magnetic Resonance System is a System, Nuclear Magnetic Resonance Imaging device. It is classified as a Class II medical device under product code LNH.

The device received FDA 510(k) clearance (K913673) on January 23, 1992, following a traditional review. It is manufactured by General Electric Co. in Milwaukee, US, and is subject to special controls under regulation number 892.1000.

Other devices from General Electric Co.

See all devices from General Electric Co. →

Questions

AI-generated answers, 1 Oct 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 Vectra Magnetic Resonance System used for?

    The Vectra Magnetic Resonance System is a nuclear magnetic resonance imaging device intended for diagnostic imaging procedures that use magnetic fields and radio waves to produce detailed images of internal body structures, as indicated by its product code LNH and classification under regulation 892.1000 for radiology applications.

  • Who manufactures the Vectra Magnetic Resonance System and where is it made?

    The Vectra Magnetic Resonance System is manufactured by General Electric Co. at their facility in Milwaukee, Wisconsin, United States, as specified in the device data showing the manufacturer location and address details.

  • What regulatory pathway was used for the Vectra Magnetic Resonance System's market authorization?

    The Vectra Magnetic Resonance System received market authorization through the FDA 510(k) traditional review process, with clearance granted under K913673 on January 23, 1992, following a determination of substantial equivalence to a legally marketed predicate device.