FDA 510(k)

星-X，口腔X光系統

K 號：K190357 · 2019-03-15

決定日期2019-03-15

產品代碼EHD

諮詢委員會DE

決定相當於

器材摘要

Star-X, Intraoral X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Hdx Will Corp.. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K190357. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Star-X, Intraoral X-ray System?

Star-X, Intraoral X-ray System is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Hdx Will Corp.. The 510(k) number is K190357.

When did Star-X, Intraoral X-ray System receive FDA 510(k) clearance?

Star-X, Intraoral X-ray System received FDA 510(k) clearance on 2019-03-15, under 510(k) number K190357.

Who is the listed applicant for Star-X, Intraoral X-ray System?

The FDA 510(k) record lists Hdx Will Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Star-X, Intraoral X-ray System?

The FDA product code for Star-X, Intraoral X-ray System is EHD.

其他以 Hdx Will Corp. 為申請人之記錄

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相關器械（代碼：EHD）

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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