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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 the device name listed in this FDA 510(k) record. The listed applicant is Ivy Biomedical Systems, Inc.. It received FDA 510(k) clearance on 2018-03-14 under 510(k) 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. The listed applicant is Ivy Biomedical Systems, Inc.. The 510(k) number is K171778.

When did MR Wireless Gating System, Model WGS-100 receive FDA 510(k) clearance?

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

Who is the listed applicant for MR Wireless Gating System, Model WGS-100?

The FDA 510(k) record lists Ivy Biomedical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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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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