FDA 510(k)

CAAS MR解決方案

K 號：K181825 · 2018-12-04

決定日期2018-12-04

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

CAAS MR Solutions is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical Imaging BV. It received FDA 510(k) clearance on 2018-12-04 under 510(k) number K181825. 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 CAAS MR Solutions?

CAAS MR Solutions is a medical device that received FDA 510(k) clearance on 2018-12-04. The listed applicant is Pie Medical Imaging BV. The 510(k) number is K181825.

When did CAAS MR Solutions receive FDA 510(k) clearance?

CAAS MR Solutions received FDA 510(k) clearance on 2018-12-04, under 510(k) number K181825.

Who is the listed applicant for CAAS MR Solutions?

The FDA 510(k) record lists Pie Medical Imaging BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAAS MR Solutions?

The FDA product code for CAAS MR Solutions is LLZ.

其他以 Pie Medical Imaging BV 為申請人之記錄

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K2503303mensio 工作站 K232147CAAS 工作站 K232007CAAS MR解決方案 K212376卡斯·喬爾迪亞 K180019CAAS 工作站 K162376CAAS MR 4D血流

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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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