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FDA 510(k)

AIMI-Triage CXR PTX

K 號:K193300 · 2020-04-08

決定日期2020-04-08
產品代碼QFM
諮詢委員會RA
決定相當於

器材摘要

AIMI-Triage CXR PTX is the device name listed in this FDA 510(k) record. The listed applicant is Radlogics, Inc.. It received FDA 510(k) clearance on 2020-04-08 under 510(k) number K193300. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AIMI-Triage CXR PTX?

AIMI-Triage CXR PTX is a medical device that received FDA 510(k) clearance on 2020-04-08. The listed applicant is Radlogics, Inc.. The 510(k) number is K193300.

When did AIMI-Triage CXR PTX receive FDA 510(k) clearance?

AIMI-Triage CXR PTX received FDA 510(k) clearance on 2020-04-08, under 510(k) number K193300.

Who is the listed applicant for AIMI-Triage CXR PTX?

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

What is the FDA product code for AIMI-Triage CXR PTX?

The FDA product code for AIMI-Triage CXR PTX is QFM.

相關臨床試驗

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相關器械(代碼:QFM)

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。

官方來源

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