qER-CTA (v1.0)
K 號：K251610 · 2025-09-08
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器材摘要
qER-CTA (v1.0) 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 2025-09-08 under 510(k) number K251610. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the qER-CTA (v1.0)?
qER-CTA (v1.0) is a medical device that received FDA 510(k) clearance on 2025-09-08. The listed applicant is Qure.Ai Technologies. The 510(k) number is K251610.
When did qER-CTA (v1.0) receive FDA 510(k) clearance?
qER-CTA (v1.0) received FDA 510(k) clearance on 2025-09-08, under 510(k) number K251610.
Who is the listed applicant for qER-CTA (v1.0)?
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 qER-CTA (v1.0)?
The FDA product code for qER-CTA (v1.0) is QAS.
其他以 Qure.Ai Technologies 為申請人之記錄
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相關器械（代碼：QAS）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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