FDA 510(k)

CS系列-FP 配 MX CFP 3131 或 MX CFP 2222 選項放射/攝影系統

K 號：K171755 · 2018-02-09

決定日期2018-02-09

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System is the device name listed in this FDA 510(k) record. The listed applicant is Omega Medical Imaging, LLC. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K171755. 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 CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System?

CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Omega Medical Imaging, LLC. The 510(k) number is K171755.

When did CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System receive FDA 510(k) clearance?

CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System received FDA 510(k) clearance on 2018-02-09, under 510(k) number K171755.

Who is the listed applicant for CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System?

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

What is the FDA product code for CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System?

The FDA product code for CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System is OWB.

其他以 Omega Medical Imaging, 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。

K242488Soteria E-View K212890尼奎斯特.IQ K212336Soteria.AI K191713CS系列-FP 放射/顯微鏡系統，附帶選購CA-100S / FluoroShield™（ROI組裝）K182834CS系列-FP 配備選購 ROI 適用配件 CA-100S

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。

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH Corporation K254205Zenition 30Philips Medical Systems Nederland B.V.K260607防護系統（西門子 30x40）Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.

官方來源

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