DENTIOIII 系列 (DENTIOIII, DENTIOIII-S)
K号: K181297 · 2018-11-21
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决定日期2018-11-21
产品代码MUH
咨询委员会DE
请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。
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器械摘要
DENTIOIII series (DENTIOIII, DENTIOIII-S) 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 2018-11-21 under 510(k) number K181297. 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 DENTIOIII series (DENTIOIII, DENTIOIII-S)?
DENTIOIII series (DENTIOIII, DENTIOIII-S) is a medical device that received FDA 510(k) clearance on 2018-11-21. The listed applicant is Hdx Will Corp.. The 510(k) number is K181297.
When did DENTIOIII series (DENTIOIII, DENTIOIII-S) receive FDA 510(k) clearance?
DENTIOIII series (DENTIOIII, DENTIOIII-S) received FDA 510(k) clearance on 2018-11-21, under 510(k) number K181297.
Who is the listed applicant for DENTIOIII series (DENTIOIII, DENTIOIII-S)?
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 DENTIOIII series (DENTIOIII, DENTIOIII-S)?
The FDA product code for DENTIOIII series (DENTIOIII, DENTIOIII-S) is MUH.
相关临床试验
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。
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）K211114Will3DK212254DENTRIa 系列 (DENTRIa, DENTRI-Ca, DENTRI-Sa)K192700XcamK190357Star-X，口腔X光系统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：MUH）
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。
K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687茧状单机（DX-7020s）Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0（VistaPano S Ceph）；VistaPano S 2.0（VistaPano S）；ProVecta S-Pan Ceph 2.0（ProVecta S-Pan Ceph）；ProVecta S-Pan 2.0（ProVecta S-Pan）VATECH Co., Ltd.K242778X传感器（型号：IOS-A15IF，HDI-15DGF）Qpix Solutions, Inc.
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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