FDA 510(k)

Yomi機器人系統

K 號：K251835 · 2025-10-10

決定日期2025-10-10

產品代碼PLV

諮詢委員會DE

決定相當於

器材摘要

Yomi 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 2025-10-10 under 510(k) number K251835. 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 Robotic System?

Yomi Robotic System is a medical device that received FDA 510(k) clearance on 2025-10-10. The listed applicant is Neocis, Inc.. The 510(k) number is K251835.

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

Yomi Robotic System received FDA 510(k) clearance on 2025-10-10, under 510(k) number K251835.

Who is the listed applicant for Yomi 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 Robotic System?

The FDA product code for Yomi 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。

K252376Yomi S機械人系統 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。

K252376Yomi S機械人系統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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