FDA 510(k)

qXR-PTX-PE

K 號：K230899 · 2023-08-22

決定日期2023-08-22

產品代碼QFM

諮詢委員會RA

決定相當於

器材摘要

qXR-PTX-PE is the device name listed in this FDA 510(k) record. The listed applicant is Qure.Ai Technologies. It received FDA 510(k) clearance on 2023-08-22 under 510(k) number K230899. 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 qXR-PTX-PE?

qXR-PTX-PE is a medical device that received FDA 510(k) clearance on 2023-08-22. The listed applicant is Qure.Ai Technologies. The 510(k) number is K230899.

When did qXR-PTX-PE receive FDA 510(k) clearance?

qXR-PTX-PE received FDA 510(k) clearance on 2023-08-22, under 510(k) number K230899.

Who is the listed applicant for qXR-PTX-PE?

The FDA 510(k) record lists Qure.Ai Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for qXR-PTX-PE?

The FDA product code for qXR-PTX-PE is QFM.

其他以 Qure.Ai Technologies 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。

K251934qXR-Detect K251610qER-CTA (v1.0)K240740qCT LN 定量 K231805qXR-LN K231149qXR-CTR K212690qXR-BT

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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。

K253751CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai)K252954MammoSightAINeurocareai, Inc. (Dba Savelife.Ai)K252482科格奈特AI-MT+Medcognetics, Inc.K250831Annalise EnterpriseAnnalise-Ai K243808Rayvolve PTX-PE 医療設備規範文本 Rayvolve PTX-PE 医療器材規範文本AZmed K243548簡易病例分類Aidoc Medical , Ltd.

官方來源

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