FDA 510(k)

核子圖像管理系統

K 號：K171130 · 2017-05-04

決定日期2017-05-04

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Nucleus Image Management System is the device name listed in this FDA 510(k) record. The listed applicant is Nucleushealth, LLC. It received FDA 510(k) clearance on 2017-05-04 under 510(k) number K171130. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nucleus Image Management System?

Nucleus Image Management System is a medical device that received FDA 510(k) clearance on 2017-05-04. The listed applicant is Nucleushealth, LLC. The 510(k) number is K171130.

When did Nucleus Image Management System receive FDA 510(k) clearance?

Nucleus Image Management System received FDA 510(k) clearance on 2017-05-04, under 510(k) number K171130.

Who is the listed applicant for Nucleus Image Management System?

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

What is the FDA product code for Nucleus Image Management System?

The FDA product code for Nucleus Image Management System is LLZ.

其他以 Nucleushealth, LLC 為申請人之記錄

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K203249核心.io

相關器械（代碼：LLZ）

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官方來源

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