FDA 510(k)

ScreenDx

K 號：K241891 · 2025-01-10

決定日期2025-01-10

產品代碼QWO

諮詢委員會RA

決定相當於

器材摘要

ScreenDx is the device name listed in this FDA 510(k) record. The listed applicant is Imvaria, Inc.. It received FDA 510(k) clearance on 2025-01-10 under 510(k) number K241891. The device is classified under product code QWO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ScreenDx?

ScreenDx is a medical device that received FDA 510(k) clearance on 2025-01-10. The listed applicant is Imvaria, Inc.. The 510(k) number is K241891.

When did ScreenDx receive FDA 510(k) clearance?

ScreenDx received FDA 510(k) clearance on 2025-01-10, under 510(k) number K241891.

Who is the listed applicant for ScreenDx?

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

What is the FDA product code for ScreenDx?

The FDA product code for ScreenDx is QWO.

其他以 Imvaria, Inc. 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。

K252041Fibresolve（含PCCP）

相關器械（代碼：QWO）

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。

K252041Fibresolve（含PCCP）Imvaria, Inc.K242467IQ-UIPImbio, Inc.

官方來源

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