FDA 510(k)

心肌應力軟體應用程序

K 號：K232661 · 2023-12-07

決定日期2023-12-07

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Myocardial Strain Software Application is the device name listed in this FDA 510(k) record. The listed applicant is Circle Cardiovascular Imaging. It received FDA 510(k) clearance on 2023-12-07 under 510(k) number K232661. 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 Myocardial Strain Software Application?

Myocardial Strain Software Application is a medical device that received FDA 510(k) clearance on 2023-12-07. The listed applicant is Circle Cardiovascular Imaging. The 510(k) number is K232661.

When did Myocardial Strain Software Application receive FDA 510(k) clearance?

Myocardial Strain Software Application received FDA 510(k) clearance on 2023-12-07, under 510(k) number K232661.

Who is the listed applicant for Myocardial Strain Software Application?

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

What is the FDA product code for Myocardial Strain Software Application?

The FDA product code for Myocardial Strain Software Application is LLZ.

其他以 Circle Cardiovascular Imaging 為申請人之記錄

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K241038心臟CT功能軟體應用程序

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。

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官方來源

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