FDA 510(k)

QLAB先進量化軟體

K 號：K200974 · 2020-06-03

決定日期2020-06-03

產品代碼QIH

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 Health Care. It received FDA 510(k) clearance on 2020-06-03 under 510(k) number K200974. The device is classified under product code QIH. 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 2020-06-03. The listed applicant is Philips Health Care. The 510(k) number is K200974.

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

QLAB Advanced Quantification Software received FDA 510(k) clearance on 2020-06-03, under 510(k) number K200974.

Who is the listed applicant for QLAB Advanced Quantification Software?

The FDA 510(k) record lists Philips Health Care 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 QIH.

其他以 Philips Health Care 為申請人之記錄

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相關器械（代碼：QIH）

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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