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Torso Array Coil, Model 558GE-64

by Igc-Medical Advances, Inc.

510(k) K041185

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 NumberK041185 Date14 May 2004ClearedStatusActive

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  • Withdrawn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
MOS
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

A torso array coil is a specialty magnetic resonance imaging (MRI) accessory designed for use with MR systems. It is used to acquire 2D/3D imaging, proton density, T1/T2 weighted imaging, time-of-flight, and phase contrast imaging.

This device is supplied as a non-sterile, reusable accessory intended for use in radiology settings. It received FDA 510(k) clearance under K041185 in 2004 and is classified as a Class II device. The coil is designed for use with GE Signa EXCITE 1.5T MR systems and must be used in accordance with the manufacturer's instructions for cleaning, maintenance, and safety.

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Questions

AI-generated answers, 25 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 Torso Array Coil Model 558GE-64 used for?

    It is used to acquire 2D/3D imaging, proton density, T1/T2 weighted imaging, time-of-flight, and phase contrast imaging in magnetic resonance imaging procedures.

  • Is the Torso Array Coil Model 558GE-64 sterile or non-sterile, and is it single-use or reusable?

    The device is supplied as a non-sterile, reusable accessory, meaning it is not provided sterile and is intended for multiple uses after proper cleaning and maintenance.

  • Which MR systems is the Torso Array Coil Model 558GE-64 designed to work with?

    It is designed for use with GE Signa EXCITE 1.5T MR systems and must be used in accordance with the manufacturer's instructions for cleaning, maintenance, and safety.