FDA 510(k)

模擬心臟計劃器

K 號：K233217 · 2024-02-12

決定日期2024-02-12

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Mimics Cardiac Planner is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2024-02-12 under 510(k) number K233217. 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 Mimics Cardiac Planner?

Mimics Cardiac Planner is a medical device that received FDA 510(k) clearance on 2024-02-12. The listed applicant is Materialise NV. The 510(k) number is K233217.

When did Mimics Cardiac Planner receive FDA 510(k) clearance?

Mimics Cardiac Planner received FDA 510(k) clearance on 2024-02-12, under 510(k) number K233217.

Who is the listed applicant for Mimics Cardiac Planner?

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

What is the FDA product code for Mimics Cardiac Planner?

The FDA product code for Mimics Cardiac Planner is LLZ.

其他以 Materialise NV 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。

K260802Materialise Shoulder System™，Materialise Shoulder Guide 及 Model，SurgiCase Shoulder Planner K251964模擬胸腔計劃器 K253308Materialise 頭顎面外科手術個人化導引和模型 CMF 鋼钛導引；CMF 塑膠模型 K253793Materialise 骨關節置换導引系統 K251554Materialise 骨關節置换導引系統 K243637Materialise個人化頭顱顏面手術導引和模型

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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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