FDA 510(k)

Sectra數位病理學模組

K 號：K193054 · 2020-03-31

決定日期2020-03-31

產品代碼QKQ

諮詢委員會PA

決定相當於

器材摘要

Sectra Digital Pathology Module is the device name listed in this FDA 510(k) record. The listed applicant is Sectra AB. It received FDA 510(k) clearance on 2020-03-31 under 510(k) number K193054. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sectra Digital Pathology Module?

Sectra Digital Pathology Module is a medical device that received FDA 510(k) clearance on 2020-03-31. The listed applicant is Sectra AB. The 510(k) number is K193054.

When did Sectra Digital Pathology Module receive FDA 510(k) clearance?

Sectra Digital Pathology Module received FDA 510(k) clearance on 2020-03-31, under 510(k) number K193054.

Who is the listed applicant for Sectra Digital Pathology Module?

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

What is the FDA product code for Sectra Digital Pathology Module?

The FDA product code for Sectra Digital Pathology Module is QKQ.

其他以 Sectra AB 為申請人之記錄

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。

K232208Sectra數位病理模組（版本3.3）

相關器械（代碼：QKQ）

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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