780 nm SPY 携帶式手持式成像 (SPY-PHI) 系統
K 號：K261037 · 2026-05-28
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器材摘要
780 nm SPY Portable Handheld Imaging (SPY-PHI) System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K261037. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the 780 nm SPY Portable Handheld Imaging (SPY-PHI) System?
780 nm SPY Portable Handheld Imaging (SPY-PHI) System is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is Stryker Endoscopy. The 510(k) number is K261037.
When did 780 nm SPY Portable Handheld Imaging (SPY-PHI) System receive FDA 510(k) clearance?
780 nm SPY Portable Handheld Imaging (SPY-PHI) System received FDA 510(k) clearance on 2026-05-28, under 510(k) number K261037.
Who is the listed applicant for 780 nm SPY Portable Handheld Imaging (SPY-PHI) System?
FDA 510(k) 記錄將 Stryker Endoscopy 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for 780 nm SPY Portable Handheld Imaging (SPY-PHI) System?
The FDA product code for 780 nm SPY Portable Handheld Imaging (SPY-PHI) System is IZI.
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。
其他以 Stryker Endoscopy 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：IZI）
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。
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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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