FDA 510(k)

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K 號：K193109 · 2020-01-24

決定日期2020-01-24

產品代碼MUJ

諮詢委員會RA

決定相當於

器材摘要

MRCAT brain is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems MR Finland. It received FDA 510(k) clearance on 2020-01-24 under 510(k) number K193109. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MRCAT brain?

MRCAT brain is a medical device that received FDA 510(k) clearance on 2020-01-24. The listed applicant is Philips Medical Systems MR Finland. The 510(k) number is K193109.

When did MRCAT brain receive FDA 510(k) clearance?

MRCAT brain received FDA 510(k) clearance on 2020-01-24, under 510(k) number K193109.

Who is the listed applicant for MRCAT brain?

The FDA 510(k) record lists Philips Medical Systems MR Finland as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRCAT brain?

The FDA product code for MRCAT brain is MUJ.

其他以 Philips Medical Systems MR Finland 為申請人之記錄

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。

K182888MRCAT 骨盤 K151435MRCAT

相關器械（代碼：MUJ）

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。

K260750虛擬圓錐（1.0）Varian Medical Systems, Inc.K253050RadOncAIInformai K260207多模態模擬工作空間（MM Sim）（v1.0.0）Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT影像套件 VC10Varian Medical Systems, Inc.

官方來源

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