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FDA 510(k)

i-CAT FLX V系列 / KaVo 3D eXam+ V系列

K 號：K162085 · 2016-11-10

申請人Imaging Sciences International
決定日期2016-11-10
產品代碼OAS
諮詢委員會RA
決定相當於

器材摘要

i-CAT FLX V series / KaVo 3D eXam+ V series is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Sciences International. It received FDA 510(k) clearance on 2016-11-10 under 510(k) number K162085. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the i-CAT FLX V series / KaVo 3D eXam+ V series?

i-CAT FLX V series / KaVo 3D eXam+ V series is a medical device that received FDA 510(k) clearance on 2016-11-10. The listed applicant is Imaging Sciences International. The 510(k) number is K162085.

When did i-CAT FLX V series / KaVo 3D eXam+ V series receive FDA 510(k) clearance?

i-CAT FLX V series / KaVo 3D eXam+ V series received FDA 510(k) clearance on 2016-11-10, under 510(k) number K162085.

Who is the listed applicant for i-CAT FLX V series / KaVo 3D eXam+ V series?

The FDA 510(k) record lists Imaging Sciences International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for i-CAT FLX V series / KaVo 3D eXam+ V series?

The FDA product code for i-CAT FLX V series / KaVo 3D eXam+ V series is OAS.

相關臨床試驗

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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相關器械（代碼：OAS）

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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官方來源

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