TumorSight Risk
K 號：K260023 · 2026-09-25
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器材摘要
TumorSight Risk is the device name listed in this FDA 510(k) record. The listed applicant is SimBioSys, Inc.. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K260023. The device is classified under product code SHW. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the TumorSight Risk?
TumorSight Risk is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is SimBioSys, Inc.. The 510(k) number is K260023.
When did TumorSight Risk receive FDA 510(k) clearance?
TumorSight Risk received FDA 510(k) clearance on 2026-09-25, under 510(k) number K260023.
Who is the listed applicant for TumorSight Risk?
The FDA 510(k) record lists SimBioSys, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TumorSight Risk?
The FDA product code for TumorSight Risk is SHW.
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其他以 SimBioSys, Inc. 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：SHW）
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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