FDA 510(k)

ULab Systems治療計劃軟體

K 號：K171295 · 2018-01-09

決定日期2018-01-09

產品代碼PNN

諮詢委員會DE

決定相當於

器材摘要

ULab Systems Treatment Planning Software is the device name listed in this FDA 510(k) record. The listed applicant is Ulab Systems, Inc.. It received FDA 510(k) clearance on 2018-01-09 under 510(k) number K171295. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ULab Systems Treatment Planning Software?

ULab Systems Treatment Planning Software is a medical device that received FDA 510(k) clearance on 2018-01-09. The listed applicant is Ulab Systems, Inc.. The 510(k) number is K171295.

When did ULab Systems Treatment Planning Software receive FDA 510(k) clearance?

ULab Systems Treatment Planning Software received FDA 510(k) clearance on 2018-01-09, under 510(k) number K171295.

Who is the listed applicant for ULab Systems Treatment Planning Software?

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

What is the FDA product code for ULab Systems Treatment Planning Software?

The FDA product code for ULab Systems Treatment Planning Software is PNN.

其他以 Ulab Systems, Inc. 為申請人之記錄

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相關器械（代碼：PNN）

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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