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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 the device name listed in this FDA 510(k) record. The listed applicant is Imidex, Inc.. It received FDA 510(k) clearance on 2023-08-03 under 510(k) 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. The listed applicant is Imidex, Inc.. The 510(k) number is K223133.

When did VisiRad XR receive FDA 510(k) clearance?

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

Who is the listed applicant for VisiRad XR?

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

What is the FDA product code for VisiRad XR?

The FDA product code for VisiRad XR is MYN.

Related Devices (Code: MYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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