FDA 510(k)

系統，X光，額外口腔來源，數位，PaX-i Plus，PaX-i Insight

K 號：K170731 · 2017-04-04

決定日期2017-04-04

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight is the device name listed in this FDA 510(k) record. The listed applicant is VATECH Co., Ltd.. It received FDA 510(k) clearance on 2017-04-04 under 510(k) number K170731. 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 System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight?

System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight is a medical device that received FDA 510(k) clearance on 2017-04-04. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K170731.

When did System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight receive FDA 510(k) clearance?

System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight received FDA 510(k) clearance on 2017-04-04, under 510(k) number K170731.

Who is the listed applicant for System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight?

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

What is the FDA product code for System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight?

The FDA product code for System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight is MUH.

其他以 VATECH Co., 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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