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FDA 510(k)

體積樣本影像儀

K 號：K192939 · 2019-12-27

申請人Clarix Imaging
決定日期2019-12-27
產品代碼MWP
諮詢委員會RA
決定相當於

器材摘要

Volumetric Specimen Imager is the device name listed in this FDA 510(k) record. The listed applicant is Clarix Imaging. It received FDA 510(k) clearance on 2019-12-27 under 510(k) number K192939. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Volumetric Specimen Imager?

Volumetric Specimen Imager is a medical device that received FDA 510(k) clearance on 2019-12-27. The listed applicant is Clarix Imaging. The 510(k) number is K192939.

When did Volumetric Specimen Imager receive FDA 510(k) clearance?

Volumetric Specimen Imager received FDA 510(k) clearance on 2019-12-27, under 510(k) number K192939.

Who is the listed applicant for Volumetric Specimen Imager?

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

What is the FDA product code for Volumetric Specimen Imager?

The FDA product code for Volumetric Specimen Imager is MWP.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：MWP）

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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官方來源

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