FDA 510(k)

PowerLook 體積評估 V4.0

K 號：K211506 · 2021-07-12

決定日期2021-07-12

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

PowerLook Density Assessment V4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Icad, Inc.. It received FDA 510(k) clearance on 2021-07-12 under 510(k) number K211506. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PowerLook Density Assessment V4.0?

PowerLook Density Assessment V4.0 is a medical device that received FDA 510(k) clearance on 2021-07-12. The listed applicant is Icad, Inc.. The 510(k) number is K211506.

When did PowerLook Density Assessment V4.0 receive FDA 510(k) clearance?

PowerLook Density Assessment V4.0 received FDA 510(k) clearance on 2021-07-12, under 510(k) number K211506.

Who is the listed applicant for PowerLook Density Assessment V4.0?

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

What is the FDA product code for PowerLook Density Assessment V4.0?

The FDA product code for PowerLook Density Assessment V4.0 is QIH.

其他以 Icad, Inc. 為申請人之記錄

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相關器械（代碼：QIH）

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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