数字口腔内X射线传感器
K号: K220277 · 2022-02-17
广告
决定日期2022-02-17
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
Digital Intraoral X-ray Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Xpectvision Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-02-17 under 510(k) number K220277. 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 Digital Intraoral X-ray Sensor?
Digital Intraoral X-ray Sensor is a medical device that received FDA 510(k) clearance on 2022-02-17. The listed applicant is Shenzhen Xpectvision Technology Co., Ltd.. The 510(k) number is K220277.
When did Digital Intraoral X-ray Sensor receive FDA 510(k) clearance?
Digital Intraoral X-ray Sensor received FDA 510(k) clearance on 2022-02-17, under 510(k) number K220277.
Who is the listed applicant for Digital Intraoral X-ray Sensor?
The FDA 510(k) record lists Shenzhen Xpectvision Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Digital Intraoral X-ray Sensor?
The FDA product code for Digital Intraoral X-ray Sensor 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Shenzhen Xpectvision Technology Co., Ltd.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.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。
广告