FDA 510(k)

Ceevra Reveal 2.0

K 號：K173274 · 2018-07-10

決定日期2018-07-10

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Ceevra Reveal 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Ceevra, Inc.. It received FDA 510(k) clearance on 2018-07-10 under 510(k) number K173274. 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 Ceevra Reveal 2.0?

Ceevra Reveal 2.0 is a medical device that received FDA 510(k) clearance on 2018-07-10. The listed applicant is Ceevra, Inc.. The 510(k) number is K173274.

When did Ceevra Reveal 2.0 receive FDA 510(k) clearance?

Ceevra Reveal 2.0 received FDA 510(k) clearance on 2018-07-10, under 510(k) number K173274.

Who is the listed applicant for Ceevra Reveal 2.0?

FDA 510(k) 記錄將 Ceevra, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Ceevra Reveal 2.0?

The FDA product code for Ceevra Reveal 2.0 is LLZ.

其他以 Ceevra, Inc. 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。

K261595Ceevra Reveal 4 K243933Ceevra Reveal 3+K233568Ceevra Reveal 3+K222676Ceevra Reveal 3 K171356清晰揭露

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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