FDA 510(k)

Yomi S機械人系統

K 號：K252376 · 2025-10-28

決定日期2025-10-28

產品代碼PLV

諮詢委員會DE

決定相當於

器材摘要

Yomi S Robotic System is the device name listed in this FDA 510(k) record. The listed applicant is Neocis, Inc.. It received FDA 510(k) clearance on 2025-10-28 under 510(k) number K252376. 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 Yomi S Robotic System?

Yomi S Robotic System is a medical device that received FDA 510(k) clearance on 2025-10-28. The listed applicant is Neocis, Inc.. The 510(k) number is K252376.

When did Yomi S Robotic System receive FDA 510(k) clearance?

Yomi S Robotic System received FDA 510(k) clearance on 2025-10-28, under 510(k) number K252376.

Who is the listed applicant for Yomi S Robotic System?

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 Yomi S Robotic System?

The FDA product code for Yomi S Robotic System 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。

K251835Yomi機器人系統 K231018Yomi機器人系統 K222750Yomi機器人系統 K222049Yomi機器人系統 K211466Yomi機器人系統搭配YomiPlan Go K210711Neocis導向系統（NGS）搭配Yomi計劃v2.0.1

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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。

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.K213392INLIANT 外科導航系統Navigate Surgical Technologies, Inc.

官方來源

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