FDA 510(k)

QLAB先進量化軟體 13

K 號：K190913 · 2019-06-18

決定日期2019-06-18

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

QLAB Advanced Quantification Software 13 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 2019-06-18 under 510(k) number K190913. 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 13?

QLAB Advanced Quantification Software 13 is a medical device that received FDA 510(k) clearance on 2019-06-18. The listed applicant is Philips Health Care. The 510(k) number is K190913.

When did QLAB Advanced Quantification Software 13 receive FDA 510(k) clearance?

QLAB Advanced Quantification Software 13 received FDA 510(k) clearance on 2019-06-18, under 510(k) number K190913.

Who is the listed applicant for QLAB Advanced Quantification Software 13?

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 13?

The FDA product code for QLAB Advanced Quantification Software 13 is LLZ.

其他以 Philips Health Care 為申請人之記錄

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K2013523D自動LAA K200974QLAB先進量化軟體 K200179合作即時 K191647QLAB先進量化軟體 K192226Lumify 診斷超音波系統 K172607飛利浦 EPIQ 5 診斷超音波系統，EPIQ 7 診斷超音波系統，Affiniti 30 診斷超音波系統，Affiniti 50 診斷超音波系統，Affiniti 70 診斷超音波系統

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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。

K261874Syneris PACS v.1.0.1.0Syneris K262442HipStudio分析Replasia BV K261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

官方來源

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