Skip to content

Coil Field Extender

by Resonex, Inc.

510(k) K911800

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK911800 Date3 Jul 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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, 20 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 Coil Field Extender is a Class II medical device designed for use in Nuclear Magnetic Resonance Imaging (MRI) systems. It is intended to extend the magnetic field coverage of MRI coils, improving imaging uniformity and quality in radiology applications.

This device is supplied as a reusable accessory for MRI systems and is intended for use in radiology settings. It does not require sterilization and is compatible with MRI environments, though specific MRI safety considerations should be reviewed per facility protocols. Authorized under FDA 510(k) clearance (K911800), it adheres to regulatory standards outlined in 892.1000.

Other devices from Resonex, Inc.

See all devices from Resonex, Inc. →

Questions

AI-generated answers, 20 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 Coil Field Extender in MRI settings?

    The Coil Field Extender is designed to enhance MRI imaging by extending the magnetic field coverage of MRI coils. This improves imaging uniformity and quality, particularly in radiology applications where consistent field strength is critical for diagnostic accuracy.

  • Is the Coil Field Extender reusable or single-use, and does it require sterilization?

    The Coil Field Extender is supplied as a reusable accessory for MRI systems. Since it is reusable, it does not require sterilization before use. However, it should be handled according to facility protocols to ensure compatibility with MRI environments and maintain safety standards.

  • What regulatory pathway was followed for the FDA clearance of this device?

    The Coil Field Extender received FDA clearance through a 510(k) submission, specifically under the Traditional clearance type. It was determined to be substantially equivalent to a predicate device and falls under the Radiology advisory committee (RA). The clearance number is K911800, and it adheres to regulatory standards outlined in 21 CFR 892.1000.

  • How is the Coil Field Extender compatible with MRI systems, and are there any special considerations for use?

    The Coil Field Extender is designed as an accessory for MRI systems and is explicitly compatible with MRI environments. While it does not require sterilization, its use should align with facility-specific MRI safety protocols to ensure proper integration with existing coils and imaging workflows. Compatibility is validated for various MRI systems, as indicated by the associated product code (LNH) and regulatory filings.