FDA 510(k)

PINPOINT 内窥镜荧光成像系统

K号: K150956 · 2016-05-23

决定日期2016-05-23

产品代码GCJ

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决定实质等同

器械摘要

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.

常见问题

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.

列明Novadaq Technologies, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K162885SPY Phi 开放场手持式荧光成像系统 K161792PINPOINT 内窥镜荧光成像系统

相关器械（代码：GCJ）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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