FDA 510(k)

PlutoX 数字口腔X光成像系统

K号: K210312 · 2021-04-23

决定日期2021-04-23

产品代码MUH

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决定实质等同

器械摘要

PlutoX Digital Intraoral X-Ray Imaging System 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 2021-04-23 under 510(k) number K210312. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PlutoX Digital Intraoral X-Ray Imaging System?

PlutoX Digital Intraoral X-Ray Imaging System is a medical device that received FDA 510(k) clearance on 2021-04-23. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K210312.

When did PlutoX Digital Intraoral X-Ray Imaging System receive FDA 510(k) clearance?

PlutoX Digital Intraoral X-Ray Imaging System received FDA 510(k) clearance on 2021-04-23, under 510(k) number K210312.

Who is the listed applicant for PlutoX Digital Intraoral X-Ray Imaging System?

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 PlutoX Digital Intraoral X-Ray Imaging System?

The FDA product code for PlutoX Digital Intraoral X-Ray Imaging System is MUH.

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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