AerFrame 患者固定系統 (AFPIS)
K 號：K260792 · 2026-05-08
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器材摘要
AerFrame Patient Immobilization System (AFPIS) is the device name listed in this FDA 510(k) record. The listed applicant is Stabilix, LLC. It received FDA 510(k) clearance on 2026-05-08 under 510(k) number K260792. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the AerFrame Patient Immobilization System (AFPIS)?
AerFrame Patient Immobilization System (AFPIS) is a medical device that received FDA 510(k) clearance on 2026-05-08. The listed applicant is Stabilix, LLC. The 510(k) number is K260792.
When did AerFrame Patient Immobilization System (AFPIS) receive FDA 510(k) clearance?
AerFrame Patient Immobilization System (AFPIS) received FDA 510(k) clearance on 2026-05-08, under 510(k) number K260792.
Who is the listed applicant for AerFrame Patient Immobilization System (AFPIS)?
FDA 510(k) 記錄將 Stabilix, LLC 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for AerFrame Patient Immobilization System (AFPIS)?
The FDA product code for AerFrame Patient Immobilization System (AFPIS) is IYE.
相關臨床試驗
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其他以 Stabilix, LLC 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。
相關器械（代碼：IYE）
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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