FDA 510(k)

Star-X，口腔X光系统

K号: K190357 · 2019-03-15

决定日期2019-03-15

产品代码EHD

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决定实质等同

器械摘要

Star-X, Intraoral X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Hdx Will Corp.. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K190357. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Star-X, Intraoral X-ray System?

Star-X, Intraoral X-ray System is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Hdx Will Corp.. The 510(k) number is K190357.

When did Star-X, Intraoral X-ray System receive FDA 510(k) clearance?

Star-X, Intraoral X-ray System received FDA 510(k) clearance on 2019-03-15, under 510(k) number K190357.

Who is the listed applicant for Star-X, Intraoral X-ray System?

The FDA 510(k) record lists Hdx Will Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Star-X, Intraoral X-ray System?

The FDA product code for Star-X, Intraoral X-ray System is EHD.

列明Hdx Will Corp.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。

K211159eco-x系列（eco-x，eco-x-s）K211114Will3D K212254DENTRIa 系列 (DENTRIa, DENTRI-Ca, DENTRI-Sa)K192700Xcam K181297DENTIOIII 系列 (DENTIOIII, DENTIOIII-S)K172168WillCeph医疗设备监管文本翻译： WillCeph医疗设备符合FDA（美国食品药品监督管理局）510(k)法规要求，PMA（上市前批准）申请中，NCT（临床试验注册号）为XXXXX，PMID（PubMed ID）为XXXXX。设备标识符：XXXXX。请访问以下网址获取更多信息：http://www.example.com/willceph

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官方来源

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