FDA 510(k)

普魯托X數位內腔X光攝影系統

K 號：K210312 · 2021-04-23

決定日期2021-04-23

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

PlutoX 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 2021-04-23 under 510(k) number K210312. 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 PlutoX Digital Intraoral X-Ray Imaging System?

PlutoX Digital Intraoral X-Ray Imaging System is a medical device that received FDA 510(k) clearance on 2021-04-23. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K210312.

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

PlutoX Digital Intraoral X-Ray Imaging System received FDA 510(k) clearance on 2021-04-23, under 510(k) number K210312.

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

The FDA product code for PlutoX 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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