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FDA 510(k)

视界雷达XR

K号: K223133 · 2023-08-03

申请人Imidex, Inc.
决定日期2023-08-03
产品代码MYN
咨询委员会RA
决定实质等同

器械摘要

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.

常见问题

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.

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相关器械(代码:MYN)

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