FDA 510(k)

MIM – 過量標記劑

K 號：K223800 · 2023-01-17

決定日期2023-01-17

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

MIM – Additional Tracers 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 2023-01-17 under 510(k) number K223800. 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 – Additional Tracers?

MIM – Additional Tracers is a medical device that received FDA 510(k) clearance on 2023-01-17. The listed applicant is Mim Software, Inc.. The 510(k) number is K223800.

When did MIM – Additional Tracers receive FDA 510(k) clearance?

MIM – Additional Tracers received FDA 510(k) clearance on 2023-01-17, under 510(k) number K223800.

Who is the listed applicant for MIM – Additional Tracers?

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 – Additional Tracers?

The FDA product code for MIM – Additional Tracers 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。

K253270Contour ProtégéAI+K251883MIM – 準確病變識別系統 Pro K250035Contour ProtégéAI+K243012MIM – 和弦HDR融合 K233620MIM - 百分位數等級量表 K232862MIM – 蒙特卡羅劑量學

查看所有 19 項裝置 →

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。