FDA 510(k)

InVision精準心臟膠質蛋白病

K 號：K243866 · 2025-05-21

申請人InVision Medical Technology Corporation

決定日期2025-05-21

產品代碼SDJ

諮詢委員會履歷

決定相當於

器材摘要

InVision Precision Cardiac Amyloid is the device name listed in this FDA 510(k) record. The listed applicant is InVision Medical Technology Corporation. It received FDA 510(k) clearance on 2025-05-21 under 510(k) number K243866. The device is classified under product code SDJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the InVision Precision Cardiac Amyloid?

InVision Precision Cardiac Amyloid is a medical device that received FDA 510(k) clearance on 2025-05-21. The listed applicant is InVision Medical Technology Corporation. The 510(k) number is K243866.

When did InVision Precision Cardiac Amyloid receive FDA 510(k) clearance?

InVision Precision Cardiac Amyloid received FDA 510(k) clearance on 2025-05-21, under 510(k) number K243866.

Who is the listed applicant for InVision Precision Cardiac Amyloid?

The FDA 510(k) record lists InVision Medical Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InVision Precision Cardiac Amyloid?

The FDA product code for InVision Precision Cardiac Amyloid is SDJ.

其他以 InVision Medical Technology Corporation 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。

K232331InVision精準LVEF (LVEF)

相關器械（代碼：SDJ）

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。

K250151US2.caEko.Ai Pte Ltd. D/B/A Us2.Ai K240860EchoGo 阿米洛德症（1.0）Ultromics Limited

官方來源

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