Galen™ 第二讀™
K 號：K241232 · 2025-01-24
廣告
器材摘要
Galen™ Second Read™ is the device name listed in this FDA 510(k) record. The listed applicant is Ibex Medical Analytics , Ltd.. It received FDA 510(k) clearance on 2025-01-24 under 510(k) number K241232. The device is classified under product code QPN. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Galen™ Second Read™?
Galen™ Second Read™ is a medical device that received FDA 510(k) clearance on 2025-01-24. The listed applicant is Ibex Medical Analytics , Ltd.. The 510(k) number is K241232.
When did Galen™ Second Read™ receive FDA 510(k) clearance?
Galen™ Second Read™ received FDA 510(k) clearance on 2025-01-24, under 510(k) number K241232.
Who is the listed applicant for Galen™ Second Read™?
The FDA 510(k) record lists Ibex Medical Analytics , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Galen™ Second Read™?
The FDA product code for Galen™ Second Read™ is QPN.
相關臨床試驗
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。
廣告