FDA 510(k)

Mars 1417X 无线数字平板探测器

K号: K210316 · 2021-03-03

决定日期2021-03-03

产品代码MQB

咨询委员会RA

决定实质等同

器械摘要

Mars 1417X Wireless Digital Flat Panel Detector is the device name listed in this FDA 510(k) record. The listed applicant is Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2021-03-03 under 510(k) number K210316. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Mars 1417X Wireless Digital Flat Panel Detector?

Mars 1417X Wireless Digital Flat Panel Detector is a medical device that received FDA 510(k) clearance on 2021-03-03. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K210316.

When did Mars 1417X Wireless Digital Flat Panel Detector receive FDA 510(k) clearance?

Mars 1417X Wireless Digital Flat Panel Detector received FDA 510(k) clearance on 2021-03-03, under 510(k) number K210316.

Who is the listed applicant for Mars 1417X Wireless Digital Flat Panel Detector?

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

What is the FDA product code for Mars 1417X Wireless Digital Flat Panel Detector?

The FDA product code for Mars 1417X Wireless Digital Flat Panel Detector is MQB.

列明Iray Technology Taicang , 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。

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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。