# K171778: MR Wireless Gating System, Model WGS-100

- Pathway: 510(k) (Traditional)
- Applicant: Ivy Biomedical Systems, Inc.
- Decided: Mar 14, 2018 after 272 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Ivy MR Wireless Gating System’s intended use is to acquire physiologic signals, comprising ECG, PP, and RESP, to provide reference outputs to trigger the acquisition and synchronization of gated images during MRI scanning in systems operating at 3.0 Tesla in strength. The MR Wireless Gating System is intended for use on adult and pediatric patients. This product is limited to use by trained and qualified medical professionals. This product is not intended for the diagnosis, treatment, or prevention of any disease nor is it intended as life support equipment. The product is restricted for use on one patient at a time and is not intended for use in home care monitoring. This product not intended to provide diagnostic clinical information with regard to patient cardiac, peripheral pulse, or respiratory monitoring. The Ivy MR Wireless Gating System is to be used in conjunction with GE Healthcare Signa Premier 3T Magnetic Resonance Scanners.

Source page: https://510kreport.com/device/K171778
Methodology: https://510kreport.com/methodology