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Vectra Magnetic Resonance System

by General Electric Co. 2 variants

510(k) K921653

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 NumberK921653 Date24 Dec 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  • Withdrawn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, 22 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 Vectra Magnetic Resonance System is a System, Nuclear Magnetic Resonance Imaging. It is classified as a Class II device with special controls.

The system is supplied by General Electric Co. and has been cleared by the FDA. It is used in the field of Radiology and has a product code of LNH. The device has a regulation number of 892.1000 and is classified as a System, Nuclear Magnetic Resonance Imaging.

Other devices from General Electric Co.

See all devices from General Electric Co. →

Questions

AI-generated answers, 22 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 Vectra Magnetic Resonance System used for?

    The Vectra Magnetic Resonance System is used in the field of Radiology for nuclear magnetic resonance imaging.

  • Is the Vectra Magnetic Resonance System cleared by the FDA?

    Yes, the Vectra Magnetic Resonance System has been cleared by the FDA with a 510K clearance.

  • What type of device is the Vectra Magnetic Resonance System?

    The Vectra Magnetic Resonance System is classified as a Class II device with special controls, specifically a System, Nuclear Magnetic Resonance Imaging.