FDA 510(k)

MIM - MRT 剂量學

K 號：K182624 · 2018-12-18

決定日期2018-12-18

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

MIM - MRT Dosimetry is the device name listed in this FDA 510(k) record. The listed applicant is Mim Software, Inc.. It received FDA 510(k) clearance on 2018-12-18 under 510(k) number K182624. 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 MIM - MRT Dosimetry?

MIM - MRT Dosimetry is a medical device that received FDA 510(k) clearance on 2018-12-18. The listed applicant is Mim Software, Inc.. The 510(k) number is K182624.

When did MIM - MRT Dosimetry receive FDA 510(k) clearance?

MIM - MRT Dosimetry received FDA 510(k) clearance on 2018-12-18, under 510(k) number K182624.

Who is the listed applicant for MIM - MRT Dosimetry?

The FDA 510(k) record lists Mim Software, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIM - MRT Dosimetry?

The FDA product code for MIM - MRT Dosimetry is LLZ.

其他以 Mim Software, 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。

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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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