GenX-CR
K号: K232158 · 2023-09-13
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决定日期2023-09-13
产品代码MUH
咨询委员会DE
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决定实质等同
器械摘要
GenX-CR is the device name listed in this FDA 510(k) record. The listed applicant is Genoray Co., Ltd.. It received FDA 510(k) clearance on 2023-09-13 under 510(k) number K232158. 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 GenX-CR?
GenX-CR is a medical device that received FDA 510(k) clearance on 2023-09-13. The listed applicant is Genoray Co., Ltd.. The 510(k) number is K232158.
When did GenX-CR receive FDA 510(k) clearance?
GenX-CR received FDA 510(k) clearance on 2023-09-13, under 510(k) number K232158.
Who is the listed applicant for GenX-CR?
The FDA 510(k) record lists Genoray Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GenX-CR?
The FDA product code for GenX-CR is MUH.
列明Genoray 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。
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