FDA 510(k)

虛擬C DRF數位影像系統

K 號：K211191 · 2021-06-24

決定日期2021-06-24

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

Virtual C DRF Digital Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Portavision Medical, LLC. It received FDA 510(k) clearance on 2021-06-24 under 510(k) number K211191. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Virtual C DRF Digital Imaging System?

Virtual C DRF Digital Imaging System is a medical device that received FDA 510(k) clearance on 2021-06-24. The listed applicant is Portavision Medical, LLC. The 510(k) number is K211191.

When did Virtual C DRF Digital Imaging System receive FDA 510(k) clearance?

Virtual C DRF Digital Imaging System received FDA 510(k) clearance on 2021-06-24, under 510(k) number K211191.

Who is the listed applicant for Virtual C DRF Digital Imaging System?

The FDA 510(k) record lists Portavision Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Virtual C DRF Digital Imaging System?

The FDA product code for Virtual C DRF Digital Imaging System is OWB.

其他以 Portavision Medical, LLC 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。

K212557虛擬C DRF-NEO數位影像系統 K191503MobileRay Pulse SE 電子影像系統

相關器械（代碼：OWB）

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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