FDA 510(k)

Brainomix 360 電腦化冠狀動脈造影檢查

K 號：K192692 · 2020-05-28

決定日期2020-05-28

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Brainomix 360 e-CTA is the device name listed in this FDA 510(k) record. The listed applicant is Brainomix Limited. It received FDA 510(k) clearance on 2020-05-28 under 510(k) number K192692. 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 Brainomix 360 e-CTA?

Brainomix 360 e-CTA is a medical device that received FDA 510(k) clearance on 2020-05-28. The listed applicant is Brainomix Limited. The 510(k) number is K192692.

When did Brainomix 360 e-CTA receive FDA 510(k) clearance?

Brainomix 360 e-CTA received FDA 510(k) clearance on 2020-05-28, under 510(k) number K192692.

Who is the listed applicant for Brainomix 360 e-CTA?

The FDA 510(k) record lists Brainomix Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Brainomix 360 e-CTA?

The FDA product code for Brainomix 360 e-CTA is LLZ.

其他以 Brainomix Limited 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。

K260406Brainomix 360 高密度 K251983Brainomix 360 緊急分類中風 K242411Brainomix 360 e-肺 K243294Brainomix 360 e-ASPECTS K242123Brainomix 360 電腦化冠狀動脈造影檢查 K233875Brainomix 360 e-肺

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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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