EZER，便携式 X 射线系统
K号: K190935 · 2019-12-19
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决定日期2019-12-19
产品代码EHD
咨询委员会DE
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决定实质等同
器械摘要
EZER, Portable X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Livermoretech, Inc.. It received FDA 510(k) clearance on 2019-12-19 under 510(k) number K190935. 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 EZER, Portable X-ray System?
EZER, Portable X-ray System is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Livermoretech, Inc.. The 510(k) number is K190935.
When did EZER, Portable X-ray System receive FDA 510(k) clearance?
EZER, Portable X-ray System received FDA 510(k) clearance on 2019-12-19, under 510(k) number K190935.
Who is the listed applicant for EZER, Portable X-ray System?
The FDA 510(k) record lists Livermoretech, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EZER, Portable X-ray System?
The FDA product code for EZER, 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Livermoretech, 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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