FDA 510(k)

Neocis導航系統（NGS）配備標記陣列支撐器（FAS）

K 號：K200348 · 2020-05-08

決定日期2020-05-08

產品代碼PLV

諮詢委員會DE

決定相當於

器材摘要

Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) is the device name listed in this FDA 510(k) record. The listed applicant is Neocis, Inc.. It received FDA 510(k) clearance on 2020-05-08 under 510(k) number K200348. The device is classified under product code PLV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)?

Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) is a medical device that received FDA 510(k) clearance on 2020-05-08. The listed applicant is Neocis, Inc.. The 510(k) number is K200348.

When did Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) receive FDA 510(k) clearance?

Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) received FDA 510(k) clearance on 2020-05-08, under 510(k) number K200348.

Who is the listed applicant for Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)?

The FDA 510(k) record lists Neocis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)?

The FDA product code for Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) is PLV.

其他以 Neocis, 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。

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相關器械（代碼：PLV）

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。

K252376Yomi S機械人系統Neocis, Inc.K251835Yomi機器人系統Neocis, Inc.K233563NavidentClaronav, Inc.K231018Yomi機器人系統Neocis, Inc.K210947NavidentClaronav, Inc.K211466Yomi機器人系統搭配YomiPlan GoNeocis, Inc.

官方來源

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