MobileX 便携式 X 射线系统
K号: K180561 · 2018-04-04
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决定日期2018-04-04
产品代码EHD
咨询委员会DE
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器械摘要
MobileX Portable X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Denterprise International, Inc.. It received FDA 510(k) clearance on 2018-04-04 under 510(k) number K180561. 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 MobileX Portable X-ray System?
MobileX Portable X-ray System is a medical device that received FDA 510(k) clearance on 2018-04-04. The listed applicant is Denterprise International, Inc.. The 510(k) number is K180561.
When did MobileX Portable X-ray System receive FDA 510(k) clearance?
MobileX Portable X-ray System received FDA 510(k) clearance on 2018-04-04, under 510(k) number K180561.
Who is the listed applicant for MobileX Portable X-ray System?
The FDA 510(k) record lists Denterprise International, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MobileX Portable X-ray System?
The FDA product code for MobileX Portable X-ray System is EHD.
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Denterprise International, Inc.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。
相关器械（代码：EHD）
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。
K260795手持式牙科X射线系统（HyperLight-M）Changzhou Sifary Medical Technology Co., Ltd.K260367便携式牙科X射线系统型号PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies CorporationK252110牙科 X-RAY 单元 (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.K254018便携式牙科X射线设备（GT-1）Guilin Refine Medical Instrument Co., Ltd.K252909诊断型X射线设备型号POCT22Ningbo Runyes Medical Instrument Co., Ltd.
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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