FDA 510(k)

Arterys 醫學科學 DL

K 號：K173542 · 2018-01-25

決定日期2018-01-25

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Arterys Oncology DL is the device name listed in this FDA 510(k) record. The listed applicant is Arterys, Inc.. It received FDA 510(k) clearance on 2018-01-25 under 510(k) number K173542. 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 Arterys Oncology DL?

Arterys Oncology DL is a medical device that received FDA 510(k) clearance on 2018-01-25. The listed applicant is Arterys, Inc.. The 510(k) number is K173542.

When did Arterys Oncology DL receive FDA 510(k) clearance?

Arterys Oncology DL received FDA 510(k) clearance on 2018-01-25, under 510(k) number K173542.

Who is the listed applicant for Arterys Oncology DL?

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

What is the FDA product code for Arterys Oncology DL?

The FDA product code for Arterys Oncology DL is LLZ.

其他以 Arterys, Inc. 為申請人之記錄

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相關器械（代碼：LLZ）

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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