EzSensor HD, EzSensor UHD
K号: K252570 · 2025-11-10
广告
决定日期2025-11-10
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。
决定实质等同
器械摘要
EzSensor HD, EzSensor UHD is the device name listed in this FDA 510(k) record. The listed applicant is Qpix Solutions, Inc.. It received FDA 510(k) clearance on 2025-11-10 under 510(k) number K252570. 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 EzSensor HD, EzSensor UHD?
EzSensor HD, EzSensor UHD is a medical device that received FDA 510(k) clearance on 2025-11-10. The listed applicant is Qpix Solutions, Inc.. The 510(k) number is K252570.
When did EzSensor HD, EzSensor UHD receive FDA 510(k) clearance?
EzSensor HD, EzSensor UHD received FDA 510(k) clearance on 2025-11-10, under 510(k) number K252570.
Who is the listed applicant for EzSensor HD, EzSensor UHD?
The FDA 510(k) record lists Qpix Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EzSensor HD, EzSensor UHD?
The FDA product code for EzSensor HD, EzSensor UHD 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Qpix Solutions, 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：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.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.K241649DUO1 和 DUO2Zinnovi, 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。
广告