FDA 510(k)

vRad PACS 內建乳房攝影功能

K 號：K162145 · 2016-10-25

決定日期2016-10-25

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

vRad PACS with Mammography is the device name listed in this FDA 510(k) record. The listed applicant is Virtual Radiologic Corporation. It received FDA 510(k) clearance on 2016-10-25 under 510(k) number K162145. 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 vRad PACS with Mammography?

vRad PACS with Mammography is a medical device that received FDA 510(k) clearance on 2016-10-25. The listed applicant is Virtual Radiologic Corporation. The 510(k) number is K162145.

When did vRad PACS with Mammography receive FDA 510(k) clearance?

vRad PACS with Mammography received FDA 510(k) clearance on 2016-10-25, under 510(k) number K162145.

Who is the listed applicant for vRad PACS with Mammography?

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

What is the FDA product code for vRad PACS with Mammography?

The FDA product code for vRad PACS with Mammography is LLZ.

其他以 Virtual Radiologic Corporation 為申請人之記錄

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K241879vRad 查覽器

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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