FDA 510(k)

NeuViz 128 多層切片電腦斷層掃描系統

K 號：K230220 · 2023-10-11

決定日期2023-10-11

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

NeuViz 128 Multi-Slice CT Scanner System is the device name listed in this FDA 510(k) record. The listed applicant is Neusoft Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2023-10-11 under 510(k) number K230220. 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 NeuViz 128 Multi-Slice CT Scanner System?

NeuViz 128 Multi-Slice CT Scanner System is a medical device that received FDA 510(k) clearance on 2023-10-11. The listed applicant is Neusoft Medical Systems Co., Ltd.. The 510(k) number is K230220.

When did NeuViz 128 Multi-Slice CT Scanner System receive FDA 510(k) clearance?

NeuViz 128 Multi-Slice CT Scanner System received FDA 510(k) clearance on 2023-10-11, under 510(k) number K230220.

Who is the listed applicant for NeuViz 128 Multi-Slice CT Scanner System?

The FDA 510(k) record lists Neusoft Medical Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeuViz 128 Multi-Slice CT Scanner System?

The FDA product code for NeuViz 128 Multi-Slice CT Scanner System is JAK.

其他以 Neusoft Medical Systems Co., Ltd. 為申請人之記錄

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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

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