FDA 510(k)

Voxel 測量儀™ v1.0

K 號：K191216 · 2019-10-17

決定日期2019-10-17

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Voxel Dosimetry™ v1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Hermes Medical Solutions AB. It received FDA 510(k) clearance on 2019-10-17 under 510(k) number K191216. 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 Voxel Dosimetry™ v1.0?

Voxel Dosimetry™ v1.0 is a medical device that received FDA 510(k) clearance on 2019-10-17. The listed applicant is Hermes Medical Solutions AB. The 510(k) number is K191216.

When did Voxel Dosimetry™ v1.0 receive FDA 510(k) clearance?

Voxel Dosimetry™ v1.0 received FDA 510(k) clearance on 2019-10-17, under 510(k) number K191216.

Who is the listed applicant for Voxel Dosimetry™ v1.0?

FDA 510(k) 記錄將 Hermes Medical Solutions AB 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Voxel Dosimetry™ v1.0?

The FDA product code for Voxel Dosimetry™ v1.0 is LLZ.

其他以 Hermes Medical Solutions AB 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。

K253835Affinity K252477雜合視覺器（00859873006240）K243919體素劑量測量（00859873006226）K241364雜合視覺器（00859873006189）K202882Affinity K193152Affinity

查看所有 13 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。