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FDA 510(k)

曲線圖像 2.0 PACS

K 號:K173101 · 2017-10-18

決定日期2017-10-18
產品代碼LLZ
諮詢委員會RA
決定相當於

器材摘要

Curve Image 2.0 PACS is the device name listed in this FDA 510(k) record. The listed applicant is Curve Dental, Ltd.. It received FDA 510(k) clearance on 2017-10-18 under 510(k) number K173101. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Curve Image 2.0 PACS?

Curve Image 2.0 PACS is a medical device that received FDA 510(k) clearance on 2017-10-18. The listed applicant is Curve Dental, Ltd.. The 510(k) number is K173101.

When did Curve Image 2.0 PACS receive FDA 510(k) clearance?

Curve Image 2.0 PACS received FDA 510(k) clearance on 2017-10-18, under 510(k) number K173101.

Who is the listed applicant for Curve Image 2.0 PACS?

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

What is the FDA product code for Curve Image 2.0 PACS?

The FDA product code for Curve Image 2.0 PACS is LLZ.

相關臨床試驗

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相關器械(代碼:LLZ)

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。

官方來源

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