赫利安視覺套件
K 號：K254265 · 2026-05-27
廣告
器材摘要
Helion Viewer Suite is the device name listed in this FDA 510(k) record. The listed applicant is Videomed Srl ( a Baxter Healthcare Corp company). It received FDA 510(k) clearance on 2026-05-27 under 510(k) number K254265. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Helion Viewer Suite?
Helion Viewer Suite is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is Videomed Srl ( a Baxter Healthcare Corp company). The 510(k) number is K254265.
When did Helion Viewer Suite receive FDA 510(k) clearance?
Helion Viewer Suite received FDA 510(k) clearance on 2026-05-27, under 510(k) number K254265.
Who is the listed applicant for Helion Viewer Suite?
The FDA 510(k) record lists Videomed Srl ( a Baxter Healthcare Corp company) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Helion Viewer Suite?
The FDA product code for Helion Viewer Suite is LLZ.
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。
相關器械（代碼：LLZ）
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