Will3D
K号: K211114 · 2021-12-15
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器械摘要
Will3D 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 2021-12-15 under 510(k) number K211114. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Will3D?
Will3D is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Hdx Will Corp.. The 510(k) number is K211114.
When did Will3D receive FDA 510(k) clearance?
Will3D received FDA 510(k) clearance on 2021-12-15, under 510(k) number K211114.
Who is the listed applicant for Will3D?
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 Will3D?
The FDA product code for Will3D is LLZ.
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）K212254DENTRIa 系列 (DENTRIa, DENTRI-Ca, DENTRI-Sa)K192700XcamK190357Star-X，口腔X光系统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
相关器械（代码：LLZ）
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。
K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio分析Replasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDS
请注意，由于您没有提供具体的医疗设备监管文本，我无法提供准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。Taiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC
官方来源
在 FDA 数据库中查看 →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。
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