FDA 510(k)

Planmed Clarity 2D 及 Clarity S 医療設備規範文本

K 號：K192317 · 2020-10-23

決定日期2020-10-23

產品代碼MUE

諮詢委員會RA

決定相當於

器材摘要

Planmed Clarity 2D and Clarity S is the device name listed in this FDA 510(k) record. The listed applicant is Planmed OY. It received FDA 510(k) clearance on 2020-10-23 under 510(k) number K192317. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Planmed Clarity 2D and Clarity S?

Planmed Clarity 2D and Clarity S is a medical device that received FDA 510(k) clearance on 2020-10-23. The listed applicant is Planmed OY. The 510(k) number is K192317.

When did Planmed Clarity 2D and Clarity S receive FDA 510(k) clearance?

Planmed Clarity 2D and Clarity S received FDA 510(k) clearance on 2020-10-23, under 510(k) number K192317.

Who is the listed applicant for Planmed Clarity 2D and Clarity S?

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

What is the FDA product code for Planmed Clarity 2D and Clarity S?

The FDA product code for Planmed Clarity 2D and Clarity S is MUE.

其他以 Planmed OY 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。

K250318計劃醫療設備 XFI K211720Planmed Clarity 2D, Planmed Clarify S K213278Planmed Verity K180918Planmed Verity K163328Planmed 清晰

相關器械（代碼：MUE）

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。

K254090I-View®Hologic, Inc.K253678MAMMOMAT B.閃耀 (11372950)Siemens Medical Solutions USA, Inc.K254092貝拉倫2D (VDMS-1000S)Vieworks Co., Ltd.K260087森諾格拉法Pristina；森諾亮HD；Pristina Serena；Pristina Serena亮GE Medical Systems SCS K243420赫西亞Genoray Co., Ltd.K2438492430TCA 配合 Xmaru WRayence Co., Ltd.

官方來源

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