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FDA 510(k)

VisiRad XR

K-Number: K223133 · 2023-08-03

ApplicantImidex, Inc.
Decision Date2023-08-03
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VisiRad XR is a medical device manufactured by Imidex, Inc.. It received FDA 510(k) clearance on 2023-08-03 under approval number K223133. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VisiRad XR?

VisiRad XR is a medical device that received FDA 510(k) clearance on 2023-08-03. It is manufactured by Imidex, Inc.. The 510(k) number is K223133.

When was VisiRad XR approved by the FDA?

VisiRad XR received FDA 510(k) clearance on 2023-08-03, under approval number K223133.

What company makes VisiRad XR?

VisiRad XR is manufactured by Imidex, Inc..

What is the FDA product code for VisiRad XR?

The FDA product code for VisiRad XR is MYN.

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Official Source

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

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