FDA 510(k)

ActivSight Intraoperative Imaging System

K 號：K231344 · 2023-08-02

決定日期2023-08-02

產品代碼OWN

諮詢委員會GU

決定相當於

器材摘要

ActivSight Intraoperative Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Activ Surgical, Inc.. It received FDA 510(k) clearance on 2023-08-02 under 510(k) number K231344. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ActivSight Intraoperative Imaging System?

ActivSight Intraoperative Imaging System is a medical device that received FDA 510(k) clearance on 2023-08-02. The listed applicant is Activ Surgical, Inc.. The 510(k) number is K231344.

When did ActivSight Intraoperative Imaging System receive FDA 510(k) clearance?

ActivSight Intraoperative Imaging System received FDA 510(k) clearance on 2023-08-02, under 510(k) number K231344.

Who is the listed applicant for ActivSight Intraoperative Imaging System?

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

What is the FDA product code for ActivSight Intraoperative Imaging System?

The FDA product code for ActivSight Intraoperative Imaging System is OWN.

其他以 Activ Surgical, Inc. 為申請人之記錄

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K203550ActivSight Intraoperative Imaging System

相關器械（代碼：OWN）

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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