FDA 510(k)

TeraRecon 心臟.心室.MR (1.0.0)

K 號：K241312 · 2024-11-05

決定日期2024-11-05

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

TeraRecon Cardiac.Chambers.MR (1.0.0) is the device name listed in this FDA 510(k) record. The listed applicant is Terarecon,Inc.. It received FDA 510(k) clearance on 2024-11-05 under 510(k) number K241312. 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 TeraRecon Cardiac.Chambers.MR (1.0.0)?

TeraRecon Cardiac.Chambers.MR (1.0.0) is a medical device that received FDA 510(k) clearance on 2024-11-05. The listed applicant is Terarecon,Inc.. The 510(k) number is K241312.

When did TeraRecon Cardiac.Chambers.MR (1.0.0) receive FDA 510(k) clearance?

TeraRecon Cardiac.Chambers.MR (1.0.0) received FDA 510(k) clearance on 2024-11-05, under 510(k) number K241312.

Who is the listed applicant for TeraRecon Cardiac.Chambers.MR (1.0.0)?

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

What is the FDA product code for TeraRecon Cardiac.Chambers.MR (1.0.0)?

The FDA product code for TeraRecon Cardiac.Chambers.MR (1.0.0) is QIH.

其他以 Terarecon,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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官方來源

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