Asimov-MKS 計影系統
K 號：K192761 · 2020-01-17
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器材摘要
Asimov-MKS Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Onlume, Inc.. It received FDA 510(k) clearance on 2020-01-17 under 510(k) number K192761. 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 Asimov-MKS Imaging System?
Asimov-MKS Imaging System is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Onlume, Inc.. The 510(k) number is K192761.
When did Asimov-MKS Imaging System receive FDA 510(k) clearance?
Asimov-MKS Imaging System received FDA 510(k) clearance on 2020-01-17, under 510(k) number K192761.
Who is the listed applicant for Asimov-MKS Imaging System?
The FDA 510(k) record lists Onlume, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Asimov-MKS Imaging System?
The FDA product code for Asimov-MKS Imaging System is IZI.
相關臨床試驗
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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
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