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FDA 510(k)

MR Wireless Gating System, Model WGS-100

K-Number: K171778 · 2018-03-14

ApplicantIvy Biomedical Systems, Inc.
Decision Date2018-03-14
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MR Wireless Gating System, Model WGS-100 is a medical device manufactured by Ivy Biomedical Systems, Inc.. It received FDA 510(k) clearance on 2018-03-14 under approval number K171778. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MR Wireless Gating System, Model WGS-100?

MR Wireless Gating System, Model WGS-100 is a medical device that received FDA 510(k) clearance on 2018-03-14. It is manufactured by Ivy Biomedical Systems, Inc.. The 510(k) number is K171778.

When was MR Wireless Gating System, Model WGS-100 approved by the FDA?

MR Wireless Gating System, Model WGS-100 received FDA 510(k) clearance on 2018-03-14, under approval number K171778.

What company makes MR Wireless Gating System, Model WGS-100?

MR Wireless Gating System, Model WGS-100 is manufactured by Ivy Biomedical Systems, Inc..

What is the FDA product code for MR Wireless Gating System, Model WGS-100?

The FDA product code for MR Wireless Gating System, Model WGS-100 is LNH.

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Related PubMed Literature

PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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