TumorSight Viz
K 號：K243189 · 2024-10-25
廣告
器材摘要
TumorSight Viz is the device name listed in this FDA 510(k) record. The listed applicant is SimBioSys, Inc.. It received FDA 510(k) clearance on 2024-10-25 under 510(k) number K243189. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the TumorSight Viz?
TumorSight Viz is a medical device that received FDA 510(k) clearance on 2024-10-25. The listed applicant is SimBioSys, Inc.. The 510(k) number is K243189.
When did TumorSight Viz receive FDA 510(k) clearance?
TumorSight Viz received FDA 510(k) clearance on 2024-10-25, under 510(k) number K243189.
Who is the listed applicant for TumorSight Viz?
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 Viz?
The FDA product code for TumorSight Viz is QIH.
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。
NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING
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：QIH）
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。
K260055syngo.CT Brain QuantificationSiemens Medical Solutions USA, Inc.K262390BoneXpertVisianaK261368Rapid Platform (R6.7)Ischemaview, Inc.K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care DiagnosticsK261677Artificial Intelligence Renal Assessment (AIRA) Version 1Aramis Global AI Consultancies, LLCK2608794DMINVIA, LLC
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