FDA 510(k)

CS系列-FP可选ROI附件CA-100S

K号: K182834 · 2019-03-29

决定日期2019-03-29

产品代码JAA

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Omega Medical Imaging, LLC为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K242488Soteria E-View K212890Nyquist.IQ K212336Soteria.AI K191713CS系列-FP X线/荧光透视系统，可选CA-100S/FluoroShield™（ROI组件）K171755CS系列-FP可选MX CFP 3131或MX CFP 2222选项的X射线/荧光透视系统

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。