FDA 510(k)

精準內視鏡式荧光成像系統

K 號：K150956 · 2016-05-23

決定日期2016-05-23

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

PINPOINT Endoscopic Fluorescence Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Novadaq Technologies, Inc.. It received FDA 510(k) clearance on 2016-05-23 under 510(k) number K150956. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PINPOINT Endoscopic Fluorescence Imaging System?

PINPOINT Endoscopic Fluorescence Imaging System is a medical device that received FDA 510(k) clearance on 2016-05-23. The listed applicant is Novadaq Technologies, Inc.. The 510(k) number is K150956.

When did PINPOINT Endoscopic Fluorescence Imaging System receive FDA 510(k) clearance?

PINPOINT Endoscopic Fluorescence Imaging System received FDA 510(k) clearance on 2016-05-23, under 510(k) number K150956.

Who is the listed applicant for PINPOINT Endoscopic Fluorescence Imaging System?

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

What is the FDA product code for PINPOINT Endoscopic Fluorescence Imaging System?

The FDA product code for PINPOINT Endoscopic Fluorescence Imaging System is GCJ.

其他以 Novadaq Technologies, Inc. 為申請人之記錄

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K162885SPY Phi 開放式手持式荧光成像系統 K161792精準內視鏡式荧光成像系統

相關器械（代碼：GCJ）

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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