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Mrgfus Pelvic Pa Coil Model 1.0

by Insightech, Ltd.

510(k) K111060

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 · Special NumberK111060 Date9 Sep 2011ClearedStatusActive

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  • Withdrawn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, 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 Mrgfus Pelvic Pa Coil Model 1.0 is a receive-only radiofrequency coil designed for magnetic resonance imaging of the pelvis and hips. It functions as an accessory to GE 1.5T MRI systems and is used in conjunction with InSightec Focused UltraSound treatment to capture radiofrequency signals from patient anatomy for image reconstruction.

This device is a Class 2 radiology accessory regulated under 21 CFR 892.1000. It has received FDA 510(k) clearance under the product code MOS.

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 primary function of the MRGFUS Pelvic PA Coil Model 1.0?

    This device is a receive-only radiofrequency coil used to capture radiofrequency signals from patient anatomy during magnetic resonance imaging of the pelvis and hips.

  • Which MRI systems is this coil compatible with?

    The coil is designed to function as an accessory specifically for GE 1.5T MRI systems to assist in image reconstruction.

  • How is this coil used in clinical procedures?

    It is used in conjunction with InSightec Focused UltraSound treatment to provide the necessary imaging data for the procedure.

  • What is the regulatory status of this device?

    The device is a Class 2 radiology accessory regulated under 21 CFR 892.1000 and has received FDA 510(k) clearance under product code MOS.