ScanX Swift 2.0，ScanX Swift View 2.0
K号: K230095 · 2023-02-06
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决定日期2023-02-06
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
ScanX Swift 2.0, ScanX Swift View 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Durr Dental SE. It received FDA 510(k) clearance on 2023-02-06 under 510(k) number K230095. 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 ScanX Swift 2.0, ScanX Swift View 2.0?
ScanX Swift 2.0, ScanX Swift View 2.0 is a medical device that received FDA 510(k) clearance on 2023-02-06. The listed applicant is Durr Dental SE. The 510(k) number is K230095.
When did ScanX Swift 2.0, ScanX Swift View 2.0 receive FDA 510(k) clearance?
ScanX Swift 2.0, ScanX Swift View 2.0 received FDA 510(k) clearance on 2023-02-06, under 510(k) number K230095.
Who is the listed applicant for ScanX Swift 2.0, ScanX Swift View 2.0?
The FDA 510(k) record lists Durr Dental SE as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ScanX Swift 2.0, ScanX Swift View 2.0?
The FDA product code for ScanX Swift 2.0, ScanX Swift View 2.0 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Durr Dental SE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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