FDA 510(k)

數位口腔X光影像系統

K 號：K212279 · 2021-10-07

決定日期2021-10-07

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

Digital Intraoral X-ray Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2021-10-07 under 510(k) number K212279. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Digital Intraoral X-ray Imaging System?

Digital Intraoral X-ray Imaging System is a medical device that received FDA 510(k) clearance on 2021-10-07. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K212279.

When did Digital Intraoral X-ray Imaging System receive FDA 510(k) clearance?

Digital Intraoral X-ray Imaging System received FDA 510(k) clearance on 2021-10-07, under 510(k) number K212279.

Who is the listed applicant for Digital Intraoral X-ray Imaging System?

The FDA 510(k) record lists Iray Technology Taicang , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Intraoral X-ray Imaging System?

The FDA product code for Digital Intraoral X-ray Imaging System is MUH.

其他以 Iray Technology Taicang , Ltd. 為申請人之記錄

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相關器械（代碼：MUH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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