先進醫學影像軟體套件 (KSWVWR)
K 號：K160334 · 2016-06-21
廣告
器材摘要
Advanced Medical Imaging Software Suite (KSWVWR) is the device name listed in this FDA 510(k) record. The listed applicant is Keosys Sas. It received FDA 510(k) clearance on 2016-06-21 under 510(k) number K160334. 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 Advanced Medical Imaging Software Suite (KSWVWR)?
Advanced Medical Imaging Software Suite (KSWVWR) is a medical device that received FDA 510(k) clearance on 2016-06-21. The listed applicant is Keosys Sas. The 510(k) number is K160334.
When did Advanced Medical Imaging Software Suite (KSWVWR) receive FDA 510(k) clearance?
Advanced Medical Imaging Software Suite (KSWVWR) received FDA 510(k) clearance on 2016-06-21, under 510(k) number K160334.
Who is the listed applicant for Advanced Medical Imaging Software Suite (KSWVWR)?
The FDA 510(k) record lists Keosys Sas as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Advanced Medical Imaging Software Suite (KSWVWR)?
The FDA product code for Advanced Medical Imaging Software Suite (KSWVWR) 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