FDA 510(k)

QLAB先進量化軟體

K 號：K181264 · 2018-06-07

決定日期2018-06-07

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

QLAB Advanced Quantification Software is the device name listed in this FDA 510(k) record. The listed applicant is Philips Ultrasound, Inc.. It received FDA 510(k) clearance on 2018-06-07 under 510(k) number K181264. 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 QLAB Advanced Quantification Software?

QLAB Advanced Quantification Software is a medical device that received FDA 510(k) clearance on 2018-06-07. The listed applicant is Philips Ultrasound, Inc.. The 510(k) number is K181264.

When did QLAB Advanced Quantification Software receive FDA 510(k) clearance?

QLAB Advanced Quantification Software received FDA 510(k) clearance on 2018-06-07, under 510(k) number K181264.

Who is the listed applicant for QLAB Advanced Quantification Software?

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

What is the FDA product code for QLAB Advanced Quantification Software?

The FDA product code for QLAB Advanced Quantification Software is LLZ.

其他以 Philips Ultrasound, 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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