FDA 510(k)

CS系列-FP 配備選購 ROI 適用配件 CA-100S

K 號：K182834 · 2019-03-29

決定日期2019-03-29

產品代碼JAA

諮詢委員會RA

決定相當於

器材摘要

CS-series-FP with Optional ROI Accessory CA-100S 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 2019-03-29 under 510(k) number K182834. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CS-series-FP with Optional ROI Accessory CA-100S?

CS-series-FP with Optional ROI Accessory CA-100S is a medical device that received FDA 510(k) clearance on 2019-03-29. The listed applicant is Omega Medical Imaging, LLC. The 510(k) number is K182834.

When did CS-series-FP with Optional ROI Accessory CA-100S receive FDA 510(k) clearance?

CS-series-FP with Optional ROI Accessory CA-100S received FDA 510(k) clearance on 2019-03-29, under 510(k) number K182834.

Who is the listed applicant for CS-series-FP with Optional ROI Accessory CA-100S?

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 Optional ROI Accessory CA-100S?

The FDA product code for CS-series-FP with Optional ROI Accessory CA-100S is JAA.

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）K171755CS系列-FP 配 MX CFP 3131 或 MX CFP 2222 選項放射/攝影系統

相關器械（代碼：JAA）

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。

K253103Nexus DRF數位X光影像系統Varex Imaging Corporation K251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLC K242488Soteria E-ViewOmega Medical Imaging, LLC K242948Adora DRFi (04550010)Nrt X-Ray A/S K233380TRIDENT 電子顯微鏡系統Dornier Medtech America K233945ProxiDiagnost N90 / 精準CRF (706110, 706400)Philips Medical Systems Dmc GmbH

官方來源

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