便携式牙科X射线系统型号PDX nova
K号: K260367 · 2026-05-27
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决定日期2026-05-27
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
Portable Dental X-ray System Model PDX nova is the device name listed in this FDA 510(k) record. The listed applicant is PDX Co., Ltd.. It received FDA 510(k) clearance on 2026-05-27 under 510(k) number K260367. 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 Portable Dental X-ray System Model PDX nova?
Portable Dental X-ray System Model PDX nova is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is PDX Co., Ltd.. The 510(k) number is K260367.
When did Portable Dental X-ray System Model PDX nova receive FDA 510(k) clearance?
Portable Dental X-ray System Model PDX nova received FDA 510(k) clearance on 2026-05-27, under 510(k) number K260367.
Who is the listed applicant for Portable Dental X-ray System Model PDX nova?
The FDA 510(k) record lists PDX Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Portable Dental X-ray System Model PDX nova?
The FDA product code for Portable Dental X-ray System Model PDX nova 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。
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.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.K251438牙科 X-Ray 设备 (Ai Ray Lite, Ai Ray Pro, Master Ray )Guilin Woodpecker 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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