IMACTIS CT導航系統
K 號：K162314 · 2018-04-24
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器材摘要
IMACTIS CT-Navigation system is the device name listed in this FDA 510(k) record. The listed applicant is Imactis, Sas. It received FDA 510(k) clearance on 2018-04-24 under 510(k) number K162314. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the IMACTIS CT-Navigation system?
IMACTIS CT-Navigation system is a medical device that received FDA 510(k) clearance on 2018-04-24. The listed applicant is Imactis, Sas. The 510(k) number is K162314.
When did IMACTIS CT-Navigation system receive FDA 510(k) clearance?
IMACTIS CT-Navigation system received FDA 510(k) clearance on 2018-04-24, under 510(k) number K162314.
Who is the listed applicant for IMACTIS CT-Navigation system?
The FDA 510(k) record lists Imactis, Sas as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IMACTIS CT-Navigation system?
The FDA product code for IMACTIS CT-Navigation system is JAK.
相關臨床試驗
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相關器械（代碼：JAK）
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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