FDA 510(k)

ANYVIEW-500R 荧光透视移动 X 射线系统

K号: K160279 · 2016-10-14

决定日期2016-10-14

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

ANYVIEW-500R Fluoroscopic Mobile X-Ray System is the device name listed in this FDA 510(k) record. The listed applicant is Ecotron Co., Ltd.. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K160279. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ANYVIEW-500R Fluoroscopic Mobile X-Ray System?

ANYVIEW-500R Fluoroscopic Mobile X-Ray System is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Ecotron Co., Ltd.. The 510(k) number is K160279.

When did ANYVIEW-500R Fluoroscopic Mobile X-Ray System receive FDA 510(k) clearance?

ANYVIEW-500R Fluoroscopic Mobile X-Ray System received FDA 510(k) clearance on 2016-10-14, under 510(k) number K160279.

Who is the listed applicant for ANYVIEW-500R Fluoroscopic Mobile X-Ray System?

The FDA 510(k) record lists Ecotron Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANYVIEW-500R Fluoroscopic Mobile X-Ray System?

The FDA product code for ANYVIEW-500R Fluoroscopic Mobile X-Ray System is OWB.

列明Ecotron Co., Ltd.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。

K221233DT-703 K180473ANYVIEW DR 系列 FPD 荧光透视移动 C 臂 ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR

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。