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MR Wireless Gating System WGS-100

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K171778

by Ivy Biomedical Systems, Inc.

Identifiers

510(k) Number
K171778 FDA 510(k)
FDA Product Code
LNH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1000 FDA 510(k)
Regulation Number
892.1000 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The MR Wireless Gating System WGS-100 is a wireless gating system designed for synchronization of radiographic image acquisition during magnetic resonance imaging (MRI). It monitors multiple physiological parameters, including electrocardiogram (ECG), photoplethysmogram (PPG), and respiration (RESP), to ensure precise timing of image capture.

This device is intended for use in MRI environments and is compatible with select 1.5T and 3T MRI host scanners. Supplied as a reusable medical device, it adheres to FDA 510(k) clearance (K171778) and EU MDR regulations. The system is classified under device class II and is regulated under the product code LNH, with a registration number 3008156140. It is not MRI-conditionally safe but is designed for use in non-MRI environments during imaging procedures.

Frequently asked questions

What physiological signals does the MR Wireless Gating System monitor during MRI procedures, and why is this important?

The MR Wireless Gating System (Model WGS-100) monitors electrocardiogram (ECG), photoplethysmogram (PPG), and respiration (RESP) to synchronize radiographic image acquisition during MRI. This precise timing ensures high-quality images by aligning scans with the patient’s cardiac and respiratory cycles, reducing motion artifacts and improving diagnostic accuracy.

Is the MR Wireless Gating System compatible with all MRI machines, and if not, which field strengths are supported?

The system is designed for use with select 1.5T and 3T MRI host scanners, but it is not MRI-conditionally safe. This means it is intended for use in non-MRI environments during imaging procedures, not inside the MRI bore. Compatibility depends on the specific MRI manufacturer and model, so verification with the manufacturer is recommended.

How is the MR Wireless Gating System supplied, and is it intended for single-use or reusable applications?

The MR Wireless Gating System (Model WGS-100) is supplied as a reusable medical device. It is not designed for single-use, meaning it can be cleaned, disinfected, and reused across multiple procedures, provided proper maintenance protocols are followed.

What regulatory pathways has the MR Wireless Gating System undergone, and how does this affect its use in clinical settings?

The system has received FDA 510(k) clearance (K171778) and complies with EU MDR regulations, classifying it as a Class II medical device under product code LNH. This clearance confirms it meets U.S. safety and performance standards for its intended use in synchronizing MRI imaging with physiological signals, ensuring it can be legally marketed and used in clinical radiology settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Technical Specifications WGS-100 MRI Wireless Gating System WGS-100, Ivy Data Sheets - Ivy Biomedical Systems, MR Wireless Gating System, Model WGS-100 (K171778) — FDA 510(k ..., DEVICE: WGS-100 Wireless Gating System (00816396023550)

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ivy Biomedical Systems, Inc.

Sources (2)

  • FDA 510(k) K171778 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026